QMS Manager Job at ICEYE (Espoo)

Sr Assoc - QA QMS

This role ensures the implementation and maintenance of Quality Management Syste...

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Ensure the implementation and maintenance of Quality Management System elements at the site
achieve compliance with global quality metrics and submit quality metrics data to the QA Head and management on time
track and implement improvement objectives identified during quality metrics presentations
evaluate departmental efficiency and ensure required training for cross-functional team members is provided
assist the QA Head in implementing Electronic Quality Management System (E-QMS) modules to handle QMS elements effectively across the plants
ensure non-conformities (NCR/SNCRs) are adequately investigated, root causes identified, and effective Corrective and Preventive Actions (CAPA) are implemented
review and approve Out of Specifications (OOS) results, ensuring timely assessment for Field Alert Report (FAR) or regulatory actions
ensure Out of Trend (OOT), Out of Limit (OOL), and Laboratory Investigation Reports (LIR) are adequately investigated
review and approve Change Control Management (CCM) and Document Change Requests (DCR) as per Standard Operating Procedures
monitor and ensure key performance indicators are maintained periodically and achieved

Job Responsibility

Ensure the implementation and maintenance of Quality Management System elements at the site
track and implement improvement objectives identified during quality metrics presentations
review and approve Out of Specifications (OOS) results, ensuring timely assessment for Field Alert Report (FAR) or regulatory actions
conduct site management reviews, NCR, OOS/OOT/OOL, and Change Control review meetings on time
support external and internal audits at the site, providing observations related to QMS compliance
monitor and ensure key performance indicators are maintained periodically and achieved.

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Health & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer.

Fulltime

Quality and Compliance Manager

This role supports a modern cleanroom facility producing a range of health and w...

Location

United Kingdom , Cheshire

Salary:

50000.00 GBP / Year

D R Newitt Recruitment

Expiration Date

Until further notice

Requirements

Experience in a quality or compliance role within food, supplements, or pharmaceuticals
Strong understanding of relevant audit standards
Working knowledge of GMP and UK/EU regulatory frameworks
Experience managing QMS and implementing process improvements
Confident communicator with strong organisational skills
Detail-focused, influential, and able to work collaboratively

Job Responsibility

Maintain site accreditation and ensure audit readiness
Manage the full audit process, including preparation and follow-up
Oversee the Quality Management System and maintain up-to-date documentation
Stay informed on relevant standards and regulatory requirements
Carry out internal audits and manage corrective and preventive actions
Support additional accreditations and customer-specific requirements
Ensure compliance with bonded warehouse regulations
Deliver training and promote awareness of quality and compliance
Work with production, supply chain, technical teams, and suppliers
Support import/export documentation, complaints, and product artwork approvals

Fulltime

Regulatory Specialist

At 2San, we are at the forefront of innovation in the global healthcare industry...

Location

United States , Norwood

Salary:

80000.00 USD / Year

2San

Expiration Date

Until further notice

Requirements

Proven regulatory affairs experience within the healthcare sector, with a focus on Class 2 and Class 3 Self-Test IVDs
Deep understanding of regulatory requirements and processes for the US market, including 510(k) management, FDA submissions, and compliance management
Experience with developing, implementing, and managing Quality Management Systems (QMS) in accordance with US and international standards, including familiarity with ISO 13485
Ability to develop and implement regulatory strategies that align with company objectives and product lifecycle
Strong analytical skills for assessing regulatory compliance, interpreting guidelines, and resolving complex issues
Excellent written and verbal communication skills for effective liaising with regulatory bodies, internal teams, and external partners
Proactive in identifying potential regulatory obstacles and developing effective solutions
Meticulous attention to detail with the capability to manage multiple projects and priorities simultaneously
Bachelor’s degree in a relevant scientific discipline (e.g., Biology, Chemistry, Biomedical Engineering) required
advanced degrees or certifications in regulatory affairs or quality assurance preferred

Job Responsibility

Monitoring and management of new and existing 510(k) entries to ensure all product listings are current and compliant with regulatory requirements
Preparing and submitting FDA applications for new product approvals and amendments for existing products, ensuring all submissions are accurate and meet regulatory standards
Maintaining the regulatory tracker to ensure all information is current and in-line with local requirements
Maintaining regular contact with manufacturers for products supplier in US. Ensuring that their conformity assessment is not due to lapse and ensuring that a plan is in place for updated certification. (IVDD to IVDR)
Regularly reviewing and updating the Quality Management System (QMS) to ensure it aligns with both US and international standards, including ISO 13485, and addressing any gaps or non-compliances
Overseeing Complaints Management and Post-Market Surveillance Activities, including the collection, analysis, and reporting of customer feedback and adverse events to regulatory bodies as required. Implementing corrective actions and ensuring continuous product quality and safety monitoring in compliance with regulatory requirements
Collaborating with product development teams to provide regulatory guidance and support from concept through to commercialization, ensuring regulatory considerations are integrated into product lifecycle management
Navigating regulatory pathways to secure product approval and market entry, including strategizing for efficient and compliant product launches
Applying strong analytical skills to assess regulatory compliance, interpret complex regulatory guidelines, and undertake risk assessments for regulatory strategies and submissions
Proactively identifying potential regulatory challenges and obstacles and working collaboratively with cross-functional teams to develop and implement effective solutions

New

Senior Quality Engineer

Role: Quality Engineer / Sr Engineer (IPQC – In Process Quality Control). Depart...

Location

India , Mahabubnagar

Salary:

Not provided

Randstad

Expiration Date

March 29, 2026

Requirements

Aware of processes needed for the QMS, GMP are identified, established, implemented and maintained as per ISO 9001:2015, ISO 15378:2017
Accountable for control and issue of documents related to QMS, GMP management systems as per Documentation system and control of documents
Accountable for control of records
Coordinate DMF related activities and amendment filings as per requirement
Ensuring the promotion of awareness of customer requirements throughout the organization
Acting as lead auditor and Conducting Internal Audits of QMS, GMP
Organizing Management Review Meetings of QMS, GMP
Conducting training and refresher training on QMS, GMP
Review the management of changes in QMS, GMP as per change control procedure
To take plant round and monitor production activities at shop floor

Fulltime

Quality Compliance Manager

The Quality Compliance Manager will lead the implementation of a customized, ris...

Location

Taiwan , Taipei

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s degree in appropriate discipline or equivalent (e.g.: Biomedical Science / Nursing etc.)
Minimum 5 years in pharmaceutical industry and good in-depth knowledge of ICH GCP standards
2 years or more experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility
Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or TrackWise
Thorough understanding of Clinical R&D activities and Global/local Regulations
Knowledge of Regulatory Submission and local/Foreign Inspection Management procedures
Quality Oversight of Clinical Trials, including clinical trial protocol development, execution, and submissions
Excellent verbal and written communication skills, including strong business writing abilities and active listening
Ability to transform business and stakeholder feedback into clear, efficient processes using a straightforward language and format
Strong analytical, critical-thinking, and decision-making abilities

Job Responsibility

Review clinical trial protocols to ensure simplification, integration of lessons learned, and identification of critical data and processes
Provide quality oversight by assessing trial risks using the Risk Assessment Categorization Tool (RACT), ensuring accurate prioritization and mitigation of risks to patient safety, data integrity, and regulatory compliance—including country-specific risks relevant to Taiwan
Lead the development and implementation of Taiwan-specific Quality Plans, establishing local expertise to ensure adherence to applicable regulations
Collaborate with Clinical Quality Therapeutic Leads to support TA-specific data integrity, including technologies for data collection and measurement (e.g., biomarkers, imaging)
Contribute to the design and execution of TA and affiliate-specific Quality Assurance plans, including audit strategies (e.g., investigator site, affiliate, and study-level audits)
Support local clinical trial and cross-functional teams in managing quality activities such as issue resolution (e.g., deviations, CAPAs, serious breaches, privacy concerns), inspection readiness, and audit/inspection management
Monitor, analyze, and report compliance metrics and trends to key stakeholders and senior leadership, providing actionable recommendations
Drive innovation by exploring and applying sophisticated quality oversight methodologies, including AI, Natural Language Processing (NLP), and data analytics

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Enterprise QMS Manager

Waymo is an autonomous driving technology company with the mission to be the wor...

Location

United States , Mountain View; San Francisco

Salary:

190000.00 - 241000.00 USD / Year

Waymo

Expiration Date

Until further notice

Requirements

Bachelor's degree in Engineering (Software, Mechanical, Electrical, Industrial), Computer Science, or a related technical field, or equivalent practical experience
7+ years of demonstrable experience developing, implementing, and auditing an enterprise-level Quality Management System (QMS) based on ISO 9001 and/or IATF 16949 and/or ISO Software standards in a regulated or safety-critical industry (e.g., Automotive, Aerospace), plus experience with ASPICE (Automotive Software Process Improvement and Capability determination)
Proven expertise in core quality methodologies, including Root Cause Analysis (RCA), Corrective and Preventive Action (CAPA), and Failure Mode and Effects Analysis (FMEA)
Flexibility to travel to vendor/partner sites 5-10% of time

Job Responsibility

Design & Implementation: Develop and implement the necessary Quality Management System (QMS) policies, procedures, and documentation across Waymo's value chain. Specifically, this role concentrates on Hardware & Software Engineering, and supply chain for autonomous vehicles
Design Control: Implement and monitor QMS processes related to Design Control (ISO 9001 Clause 8.3) for the "Waymo Driver" autonomous technology, ensuring requirements traceability, design reviews, verification, and validation activities align with the framework
Process Conformity: Ensure Software Development Life Cycle (SDLC) processes conform to defined quality standards, covering planning, requirements gathering, development, and testing of software solutions
Change Management: Develop and audit robust Change Management protocols (ISO 9001/IATF 16949) for software releases, feature updates, and bug fixes to systematically plan, assess risks, verify effectiveness, and eliminate adverse effects of changes before deployment
Supplier Quality Management: Collaborate with Supply Chain and Procurement to define and implement QMS requirements for suppliers, ensuring adherence to standards like IATF 16949 and verifying that components and services meet the highest standards of specification and reliability
Risk & Issue Resolution (CAPA): Lead Root Cause Analysis (RCA) and administer the Corrective and Preventive Action (CAPA) system across the federated structure to address non-conformities related to hardware, tooling, and operational procedures, ensuring universal application of lessons learned

What we offer

discretionary annual bonus program
equity incentive plan
generous Company benefits program
top-notch medical, dental and vision insurance
mental wellness support
gym membership
special wellness programs
competitive compensation
bonus opportunities
equity

Fulltime

Manager, Quality Systems (QMS)

As the Manager, Quality Systems, you will support the design, implementation, an...

Location

Canada , Vancouver

Salary:

94880.00 - 118600.00 CAD / Year

AbCellera Biologics

Expiration Date

Until further notice

Requirements

5+ years of experience managing quality systems in a GxP-regulated environment, with demonstrated application of global CMC/GMP requirements and relevant regulations and guidance
Bachelor’s degree in a relevant scientific or engineering discipline with 8+ years of industry experience in biotechnology, pharmaceuticals, or life sciences
Strong understanding and hands-on experience with quality management systems and continuous improvement principles, including their application to QC laboratory operations and regulated environments
Solid understanding of drug development processes from discovery through CMC development, with the ability to translate business and regulatory requirements into practical, compliant solutions
Experience supporting, configuring, or owning QC laboratory electronic systems (e.g., LIMS, LES, CDS) in a GMP-regulated environment, including system lifecycle management and change control
Proactive in identifying opportunities for improvement, with strong critical thinking and problem-solving skills

Job Responsibility

Establishing, supporting, maintaining, monitoring, and continuously improving the QC Quality Management System (QMS) framework and associated quality system processes in compliance with applicable global CMC/GMP requirements
Supporting the operation, administration, and lifecycle management of QC laboratory electronic systems (eSystems), ensuring they effectively support sample management, analysis, data acquisition, data review, and result reporting in compliance with global GMP, data integrity, and regulatory requirements
Contributing to the design, implementation, and evolution of the QC data architecture, identifying eSystem capabilities needed to support QC workflows, data integrity (ALCOA++), and phase-appropriate compliance
Serving as the Business Process Owner (BPO) for QC laboratory systems (e.g. LIMS, LES, CDS), overseeing system changes, enhancements, and upgrades throughout the system lifecycle
Overseeing and maintaining QC eSystems master data, including user roles, permissions, system configurations, and controlled data objects
Developing, reviewing, and maintaining GMP procedures, work instructions, controlled documentation, and training materials governing the compliant and effective use, administration, and data management of QC eSystems, including delivery of end-user training sessions
Providing QC eSystem support for investigations, deviations, and CAPAs, including data retrieval, audit trail review, and system impact assessments
Supporting qualification and computer system validation activities for QC systems (e.g., protocol and risk assessment review, validation deviations/exceptions, and lifecycle documentation)
Managing QC eSystem licensing, user access, vendor relationships, and budgeting/forecasting for QC digital infrastructure
Collaborating cross-functionally with QC, Quality Systems, IT, Engineering, Validation, and external vendors to ensure QC eSystems are fit-for-purpose, compliant, and aligned with laboratory and business processes

What we offer

Equity
Annual bonus dependent on team and company performance
6% (non-match) RRSP contribution
CAD $1,500 annual Active Lifestyle Allowance
Annual vacation
Professional development opportunities
Comprehensive health benefits
Scientific and technical mentorship
Teams and social groups to build community and connections

Fulltime

Quality Controller – Logistics

Location

Ireland , Swords

Salary:

50000.00 EUR / Year

Executive Talent

Expiration Date

Until further notice

Requirements

Minimum of 3 years’ experience in a quality or compliance role within pharma / logistics/freight forwarding or supply chain
Relevant third level qualification in Quality Management, Logistics or related discipline
Experience in pharmaceutical logistics and GDP environments highly desirable
Knowledge of relevant ISO standard
Experience with CAPAs & Validation is essential
Experience managing internal & external audit experience
Proficient in MS Office Suite (Word, Excel) and quality management systems (QMS)

Job Responsibility

Manage and maintain existing Quality Management System
Monitoring quality performed by other departments to ensure it meets the established standards
Ensuring that quality requirements are met by entities placed under the control of the quality department
Creation and maintenance of consistent documentation in line with ISO9001 standards
Ensuring continuous review to identify problems within new/existing processes
Correcting problems when found by identifying resources, initiating a problem resolution procedure and corrective action plan when necessary
Ensuring, from a quality perspective, that products/services meet the required standards consistently
Manage any issues through a defined risk assessment/corrective action framework
Monitoring the progress and ensuring effective closure of all corrective action plans
Performing testing/inspections when required to verify that corrective actions are implemented effectively

Fulltime

QMS Manager

ICEYE

Location:
Finland , Espoo

Category:
Quality Control

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 15, 2026

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