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

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

New

Quality Manager & Responsible Person (RP)

The Quality Manager & RP supports the Responsible Person in maintaining complian...

Location

United Kingdom , Northampton

Salary:

Not provided

Healthxchange

Expiration Date

Until further notice

Requirements

Batchelors degree in related field (Quality Assurance, life sciences etc)
Minimum of 3 years’ experience in a QA role in pharma industry (GDP, GMP, GxP)
Experience in GxP QMS management
Previous RP experience on WDA(H) (preferably with the same licence conditions)
Strong analytical, problem-solving and decision-making skills
Effective communication and interpersonal skills
Excellent attention to detail with strong analytical skills
Ability to work independently and collaboratively across multiple cross-functional departments
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint)

Job Responsibility

Support the implementation & maintenance of Healthxchange’s commitment towards GDP, GMP and GPhC Regulatory standards
Provide daily support towards Healthxchange’s operations licences at all sites
namely WDA(H) & MS licenses
Assist the Head of Quality in implementing and maintaining applicable standards across all Healthxchange operations
Act as the Responsible Person
Oversight and maintenance of the Quality Management System (QMS) including document control, change management, deviation and CAPA management, complaint management and validation activities
Assist in the development and improvement of procedures, protocols and departmental documentation
Support customer, supplier qualification and re-qualification
Outsourced activities qualification
Partake and support internal and external audits to assess compliance whilst continually removing risk from Healthxchange operations

What we offer

Company pension
annual performance bonus
25 days holiday plus bank holidays (and increasing with service)
staff discount
staff social events
access to Health Assured EAP

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

New

Director, Quality Assurance

This role leads the Quality Assurance function for a medical device company spec...

Location

Canada , Mississauga

Salary:

150000.00 - 200000.00 CAD / Year

Profound Medical

Expiration Date

Until further notice

Requirements

A minimum of a bachelor’s degree in engineering (Mechanical, Electrical, Biomedical, Systems, or related field)
Quality Assurance certification (ASQ CQE, CQA, CMQ/OE) is an asset
10+ years of experience in Quality Assurance within the medical device industry
5+ years of leadership experience in a regulated manufacturing environment
Deep expertise in ISO 13485, ISO 14971, and medical device quality system practices
Strong engineering background with hands-on experience in: Design transfer
Process validation
Manufacturing quality controls
DMR/DHR management
Root cause analysis and problem-solving methodologies

Job Responsibility

Lead the development, implementation, maintenance, and continuous improvement of the regulatory compliant QMS
Serve as the Management Representative, reporting to senior management on QMS performance and improvement opportunities
Ensure effective document control, training, internal audits, CAPA, nonconformance management, supplier quality, and change control processes
Partner closely with R&D to ensure design controls are rigorously applied throughout the product lifecycle
Lead risk management activities (ISO 14971, DFMEA, PFMEA) and ensure risk files remain current and comprehensive
Ensure verification, validation, and usability engineering activities meet quality and safety requirements
Lead design transfer from R&D to manufacturing, ensuring readiness of processes, documentation, and controls
Conduct manufacturability assessments and collaborate with engineering to optimize product design for production efficiency and reliability
Oversee process validation (IQ/OQ/PQ) for manufacturing processes, test methods, and equipment
Ensure effective deployment and maintenance of the Device Master Record (DMR) and Device History Record (DHR)

What we offer

group RRSP
medical benefits paid by the employer

Fulltime

Regional Quality Manager

The Regional Quality Manager is responsible for leading and maintaining quality ...

Location

United States , New Jersey or Minnesota

Salary:

90000.00 - 110000.00 USD / Year

Aquent

Expiration Date

Until further notice

Requirements

7+ years of progressive experience in quality management within a regulated or manufacturing environment
Experience managing quality systems across multiple sites or locations
Strong knowledge of QMS, audits, CAPA, and continuous improvement methodologies
Demonstrated leadership and ability to influence cross-functional teams
Familiarity with digital QMS tools and data-driven quality reporting

Job Responsibility

Oversee regional implementation and effectiveness of the Quality Management System (QMS) in alignment with corporate standards and applicable regulations
Ensure consistent application of quality policies, procedures, and work instructions across all sites in the region
Monitor regulatory and standards changes and assess regional impact
Lead preparation and execution of internal, external, customer, and regulatory audits
Support site teams during customer inspections and act as a regional point of contact for quality-related findings
Ensure timely and effective responses to audit observations, including root cause analysis and corrective actions
Oversee regional CAPA processes to ensure effective investigation, root cause determination, and sustainable corrective actions
Track CAPA trends and performance metrics
escalate risks as needed
Define, monitor, and report regional quality KPIs

What we offer

Bonus Structure

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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