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

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

Plant head

The Plant Head will be responsible for the overall strategic and operational lea...

Location

India , Hyderabad

Salary:

Not provided

Randstad

Expiration Date

January 30, 2026

Requirements

Minimum 20 years of experience in managing and executing MEP systems for large-scale EPC /Design-Build infrastructure and industrial projects
Experience with international consultants and national clients
In-depth technical and execution knowledge across mechanical, electrical, plumbing, firefighting, HVAC, drainage, stormwater, and ELV systems
Strong expertise in design coordination, shop drawing review, execution monitoring, testing, commissioning

Job Responsibility

Strategic Planning: Develop and execute the annual production plan, ensuring alignment with organizational goals for volume, cost, and quality
Efficiency: Optimize production processes, resource utilization, and yield maximization while strictly adhering to cGMP guidelines
Capacity Planning: Oversee the planning, scheduling, and control of all manufacturing, packing, and associated activities to achieve maximum operational efficiency
Compliance Leadership: Be the final authority at the site for all Quality and Regulatory matters. Ensure strict adherence to national and international regulatory requirements (e.g., USFDA, MHRA, TGA, WHO-GMP)
Audit Management: Lead and coordinate all internal, customer, and regulatory audits (e.g., USFDA inspections). Ensure timely and effective closure of all CAPAs (Corrective and Preventive Actions)
QMS Implementation: Champion a robust Quality Management System (QMS) across all functions
Budgeting: Develop, manage, and control the annual operating and capital expenditure (CAPEX) budget for the site
Cost Optimization: Drive initiatives for cost reduction and waste minimization without compromising product quality or safety standards
Inventory Control: Oversee material management, including procurement, storage, and inventory control of raw materials and finished goods
SHE Culture: Foster a proactive and zero-incident culture for Safety, Health, and Environmental protection

Fulltime

Quality Control Manager

This position shall have overall responsibility for the contractor's quality con...

Location

United States , West Point

Salary:

80000.00 - 110000.00 USD / Year

CBRE Government & Defense Services

Expiration Date

Until further notice

Requirements

Associate degree in related field
3 years' experience in preparing and enforcing quality management programs (QMS) on contracts of similar size, scope and complexity
2+ years of experience in quality control evaluation and reporting in the fields of construction or facility management work
2+ years of experience working in comparably sized health facilities
OHSA Certifications, highly preferred
Knowledge of OSHA safety regulations and PPE procedures
Ability to conduct accident investigations and safety inspections
Strong written and oral communication skills

Job Responsibility

Administer quality control management program
Responsible for overall quality assurance program
Monitor and inspect all delivery orders for compliance
Maintain records of inspections and certifications
Prepare monthly reports depicting findings of quality inspections
Periodically review the quality control program to ensure compliance
Examine processes for preventative and corrective maintenance
make suggestions based on findings
Perform inspections and re-inspections to ensure problems have been resolved
Collect data for the DMLSS system including work orders and equipment history

What we offer

medical
well-being
financial planning
short-term benefits

Fulltime

Engineering Manager

Alliance Medical Radiopharmacy offers an exciting opportunity for an Engineering...

Location

United Kingdom , Sutton

Salary:

Not provided

Alliance Medical Ltd

Expiration Date

Until further notice

Requirements

A degree-level qualification or higher in an engineering discipline or a related field
Previous experience in site maintenance and operations
Experience in managing and implementing a preventative maintenance schedule
Understanding of Quality Management Systems (QMS) and Good Manufacturing Practice (GMP)
The ability to think logically and follow instructions precisely
A strong awareness of health and safety protocols

Job Responsibility

Coordinating and overseeing facilities maintenance
Managing preventative maintenance schedules at production facilities
Maintaining the equipment and facility in operational status for the production of 18Fluorine and the subsequent synthesis and dispensing of radiopharmaceuticals

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

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for QMS Manager

Sr Assoc - QA QMS

Quality and Compliance Manager

Regulatory Specialist

Quality Compliance Manager

Enterprise QMS Manager

Plant head

Quality Control Manager

Engineering Manager

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

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for QMS Manager

Sr Assoc - QA QMS

Quality and Compliance Manager

Regulatory Specialist

Quality Compliance Manager

Enterprise QMS Manager

Plant head

Quality Control Manager

Engineering Manager

Location:
Finland , Espoo

Category:
Quality Control

Contract Type:
Not provided

Job Posted:
January 15, 2026