QMS Specialist Job at Demant (Vallauris (Sophia Antipolis))

Qa specialist

Responsible for executing the food safety and quality strategy for the Specialty...

Location

Netherlands , Amsterdam

Salary:

Not provided

ADM

Expiration Date

Until further notice

Requirements

Bachelor's degree in food technology, Quality Management, or related field
3+ years of experience in quality management in the food industry
Strong knowledge of food safety standards and quality systems (HACCP, GMP, QMS)
Experience with supplier quality and auditing processes
Skilled in process improvement and root cause problem-solving methodologies
Excellent communication skills with the ability to work collaboratively across departments
Proactive, solution-oriented, and able to prioritize multiple tasks in a dynamic environment
Fluent in English
Dutch proficiency preferred

Job Responsibility

Ensure food safety and quality compliance for products distributed in EMEA, aligned with ADM policies, regulatory requirements, and customer standards
Collaborate closely with factory Quality Managers and Technical Support teams globally (EU, USA, India, Serbia) to optimize quality across the supply chain
Provide proactive support and consultation to management on quality issues, regulatory compliance, and food safety improvements
Conduct and coordinate internal and external audits
host auditors from customers, certification bodies, and governmental agencies
Train internal teams on food safety, GMP, and quality principles to ensure compliance awareness
Maintain and update quality documentation, including product specifications and Certificates of Analysis (CoA)
Manage returned goods workflows, including review, disposition, and corrective actions
Support supplier and co-packer qualification, maintaining approval of documentation and performance records
Manage product certifications such as Kosher, Halal, and Non-GMO

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

Operations Compliance Specialist

Reporting to the Inspection Readiness Lead, the Operations Compliance Specialist...

Location

Ireland , Cork

Salary:

Not provided

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

2+ years’ experience in technical writing and compliance
Proficient in data analytics, data visualization
Working knowledge in Regulations, GMP, GDP
2+ working within a regulated healthcare industry including a role in capacity of quality and compliance
Strong verbal, written and oral communication skills
Able to work independently and be flexible to changing priorities

Job Responsibility

Manage the authoring & drafting of all types of Manufacturing Operations documentation
Specifications & associated forms in conjunction with the various departmental subject matter experts (SME)
Support document updates and manage timelines for cross functional Projects
Act as a SME/Superuser on the Controlled Document System to facilitate the processing & approval of documents
Organise & Facilitate Document Round Table meetings with cross functional teams as required
Mange and build Quality Veeva QMS metrics for Manufacturing Operations
Coach & Train colleagues in Documentation System & GDP queries
Support manufacturing operations on meeting deadlines on Veeva QMS records
Update compliance procedures and processes
Generate Reports/Metrics & analyze trends as required including but not limited to: Veeva QMS reports, Doc Tracker Lookaheads, ASI/AIC metrics, Logbook Metrics, Doc Tracker Metrics, RFT Metrics

Senior Subsea Pipeline Marine Inspector

Airswift are a Global Manpower Provider specializing in the Energy, Infrastructu...

Location

Qatar , Doha

Salary:

Not provided

Airswift Sweden

Expiration Date

Until further notice

Requirements

Bachelor’s degree in engineering discipline (Mechanical) with demonstrated knowledge and experience
CSWIP 3.4UC Underwater Inspection Controller (Ref. CSWIP Document No.CSWIP-DIV-7-95 – Part 2)
Current / valid BOSIET, TBOSIET, FOET or TFOET certificate (Ref. OPITO requirements), as applicable, in conjunction with an offshore medical certificate
Experience in conducting QMS audits and QA verification programs for various project phases (i.e., Engineering, Procurement, Construction and Installation (specifically, the Repair / Installation of pipelines and their associated infrastructure) would be preferable
At least six (6) years of working experience in Quality Assurance and Control (QA/QC) within the Oil and Gas industry (i.e., onshore and offshore)
Should have a proven history as a lead 3.4UC underwater inspection controller within demanding subsea/offshore projects
Subsea pipeline project experience is highly desired, with emphasis on pipeline operations, integrity assurance/non-destructive testing (NDT) and inspection, maintenance and/or design and construction
Familiarity with marine vessel operations and the organisational responsibility of the (i) Offshore Construction/Installation Manger, (ii) Vessel Master, (iii) Diving and ROV Supervisors, (iv) Client Representative(s), (v) Certifying Authorities, etc.
Knowledge and working experience of underwater inspection (UWI) in the form of visual inspection and non-destructive testing (NDT) conducted by means of the intervention of diver(s) and/or remotely operated vehicle (ROV) or crewed submersible (i.e., either as a practitioner and/or as the result of training or certification conforming to the requirements of CSWIP Document No. CSWIP-DIV-7-95 – Part 1 and 2)
With respect to UWI and other related activities, shall be familiar with (i) relevant subsea applied inspection systems, (ii) recording and processing of data, (iii) quality assurance (QA), (iv) inspection planning and briefing, (v) the capabilities and limitations of divers/ROV’s and submersibles, and (vi) the care and deployment of equipment

Job Responsibility

Ensure compliance with QatarEnergy LNG systems and processes, including the Project Management System. Engage contractors and applicable third-party organisations with a professional approach and maintain a good working level relationship
Have a knowledge of the front end engineering design (FEED) deliverables and engineering study reports to support the implementation of the Project Quality Plan (PQP) and associated Procedures
Review the project Scope of work, to determine the nature, extent, and frequency of quality verification activities
Monitor, evaluate and report the inspection and testing status of the pipeline repair activities
Maintain interface relationships with Subsea Pipeline Repair Installation, and Inspection Contractors (including nominated specialist third-party Contractor organisation(s)), and the applicable regulatory focal points
especially, those functioning offshore
Review Contractor’s and Vendor’s quality reports / deliverables, in line with the project quality requirements
In conjunction with the QA/QC delegation operating offshore, verify that the repair activities are in accordance with approved documented information (i.e. procedures, specifications, detailed methodologies, etc)
Support the underwater inspection (UWI) activities during the offshore / subsea repairs, by means of the development of job records, preparation of daily reports, review of diver commentary and transfer into the written form, interpretate ROV camera footage and transfer into the written form and be able to produce an oral commentary of the daily activities, as and when required
Monitor the technical inspections, verification, certification and acceptance by Specialist Third Party Inspection (TPI) Contractor, as applicable, and develop the final documentation for each offshore campaign (i.e., PL-49, PL-75, PL-610 and PL-811)

Fulltime

New

Qa quality specialist

This position reports to the Associate Director, External Quality, Quality Syste...

Location

Ireland , Cork

Salary:

Not provided

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

Bachelor’s Degree in science or engineering
Minimum 3+ years of biopharmaceutical experience in a Quality, Compliance, and/or Regulatory setting
Skilled in data analysis and excel
Strong communication and interpersonal skills – Oral, written and presentation skills
Works collaboratively with others to meet shared objectives.

Job Responsibility

Perform the Quality Systems Metric Review for External Quality and oversee relevant metrics and trending for each quality system to proactively drive on-time closure of Quality records
Responsible for managing routine cross-functional meetings to ensure timely closure of Deviations, CAPAs and Change Control, with leadership endorsement
Responsible for development/reporting of metrics and supporting standardization of these across the Organization
Co-ordinate monthly governance site quality review team (SQRT) meeting for GEO / External Quality
Deliver training on Quality Management Systems, as required
Partner with the Global Quality Systems Management Team and other cross functional groups to ensure proper application of the QMS
Identify and implement continuous improvement initiatives to the External Quality systems
Assist as needed in audits and inspections
Participate in development and implementation of global alignment projects with BioMarin’s sister sites
Manage the Self Inspection Programme for External Quality

Technical Success Specialist – F.I.S.H Solutions

The Technical Success Specialist is a position that provides customer service, p...

Location

United States of America , Boston

Salary:

Not provided

MetaSystems International

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Life Sciences, Engineering, Physics, Chemistry, or relevant field
Highly detail-oriented, flexible team player, quick learner
Excellent communication and organizational skills
Self-motivated to intensify knowledge and expertise
Works well under time constraints and communicates clearly and diplomatically with customers
3+ years of laboratory experience, preferably in FISH assay development or cytogenetics laboratories
Familiarity with quality management systems and procedures
Knowledge of Office software suite, ERP, and other business operation software

Job Responsibility

Visit customers to install/maintain hardware and software, train users and provide technical support
Answer customer support calls and emails, provide remote troubleshooting when necessary
Strong understanding of FISH wet lab workflows, including sample preparation, hybridization, and imaging steps
Ability to troubleshoot probe performance issues and identify root causes impacting signal quality optimization
Collaborative with other MetaSystems personnel on Application based projects
Document customer interactions in ERP and update device history records, as required in our QMS
Keep up with training on new products, software, hardware and processes
Able to perform basic user training on MetaSystems products
Communicate effectively, diplomatically, and professionally with colleagues and customers
Support and collaborate with other MetaSystems departments as needed

Fulltime

Clinical QA Specialist II

The Clinical Quality Specialist will own data quality generated in Loyal’s pre-c...

Location

United States

Salary:

75000.00 - 95000.00 USD / Year

Loyal

Expiration Date

Until further notice

Requirements

Bachelor’s degree or equivalent experience required, preferably in animal science, biology, veterinary, or related life sciences
3+ years experience in GCP animal health studies (non human health studies), clinical development or operations, or QA
Excellent communication, presentation, and interpersonal skills
Exceptional organizational and follow-up skills, as well as attention to detail
Able to travel up to 40% regionally and nationally
Working knowledge of regulations, standards, and guidances for Good Laboratory Practice and (Veterinary) Good Clinical Practice
Proficiency in electronic data capture systems and study drug inventory management systems
Ability to analyze complex problems and develop multiple solutions within regulatory guidance

Job Responsibility

Participate in a rigorous quality control program for Loyal’s clinical team
Site visits to clinical trial sites (vet clinics) with clinical research associates (CRAs) to ensure procedural quality at the data collection source
Assist in maintaining and organizing quality management system (QMS) documentation, including SOPs, CAPAs, and training records
Provide/support GCP guidance on questions arising from day to day clinical trial activities
Support clinical teams with quality-related questions, document requests, and system access
Identifying discrepancies and inconsistencies in data collection and, if necessary, providing remediation or training to the clinical operations team
Working closely with CRAs to standardize data collection methods and quality processes from site initiation through study close out
Utilize guidance documents and standards to interpret for guidance, ensuring quality and compliance to regulations
Support preparation for internal and external audits, including vendor and site audits
Help track and follow up on audit findings, deviations, and corrective/preventive actions (CAPAs)

What we offer

Full-coverage health insurance — medical, dental and vision — for you and your dependents
$1,000 home office equipment stipend
$1,200/year learning budget for books, courses, etc.
$250/month wellness budget for gym, cleaners, spa, food, etc.
All 3-day weekends are turned into 4-day weekends
Unlimited vacation and paid holidays
Paw-ternity leave — adopt a dog and get a day off with your new family member
Competitive salary
Company equity options grant for new hires

Fulltime

QA senior specialist

Lead quality initiatives and build a thriving QA function within a dynamic inter...

Location

Japan , Tokyo

Salary:

6000000.00 - 10000000.00 JPY / Year

Randstad

Expiration Date

May 13, 2026

Requirements

3+ years of experience in Quality Assurance within a regulated IVD/MD company
Experience working in an international organization
Experience supporting audits with Competent Authorities/Notified Bodies
Excellent written and spoken English
Strong understanding of Japanese regulations for Molecular Diagnostics (IVDs) and Devices
Proven ability to lead projects and drive continuous improvement initiatives
Experience with eQMS and eDMS/eTMS systems
Strong collaboration and communication skills
Problem-solving and analytical skills
Experience working with 3PLs or warehouse management is a plus

Job Responsibility

Lead quality initiatives and build a thriving QA function within a dynamic international team
Lead local project implementations and contribute to larger global projects
Maintain and improve the company's QMS, implementing local solutions as needed
Manage quality systems such as document control, utilizing global eQMS and eDMS/eTMS systems
Support internal, external (regulatory/Notified Body), and supplier audits
Collaborate with the Global CAPA team to resolve customer issues related to molecular diagnostic (MDx) products
Partner with the Warehouse/3PL team to ensure efficient operations, including product release and re-labeling
Handle quality-related inquiries

What we offer

健康保険
厚生年金保険
雇用保険
土曜日
日曜日
祝日

Fulltime

QMS Specialist

Demant

Location:
France , Vallauris (Sophia Antipolis)

Category:
Quality Control

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 01, 2026

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