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Senior QM Medical Device Officer
PharmathenQM Medical Device Senior Officer at Pharmathen developing and managing quality systems for medical devices. Involves quality management throughout the product lifecycle and collaboration across teams.
About the role
Key responsibilities & impact- Participate in the development of a quality management system for medical devices and combination products in accordance with applicable standards and regulations, i.e. ISO 13485, EU MDR regulation and US-FDA 21 CFR Part 4 and 820 and provide leading assistance in the preparation for company certification if necessary
- Ensure that the quality management system remains up to date, covering the current requirements of the above legislation relating to the combination of products and medical devices
- Provide assessment and support R&D and rest involved departments in quality management issues related to combination products and medical devices
- Participate in supplier audits whether it is necessary providing input in the compilation of the audit report
- Participate in audits/ inspections performed by customers, authorities and notified bodies supporting tasks related to combination products and medical devices
- Represent cQM and monitors the effectiveness of quality management tools in R&D and rest involved departments projects
- Answer to customer enquiries around medical devices and regulations for quality-relevant topics
- Communicate with medical device suppliers to monitor their changes and support the evaluation of the impact of such changes to company’s combination product
- Assist in response to Audit observations related to QMS activities of medical device/ combination products
- Assist in the development of documentation and record resulting from quality management system activities and according to established procedures including DHF
- Develop and adhere to strict project timelines
- Actively participate in multiple customer projects to support submission and launch preparation in different markets and communicate with suppliers for any specific requirement
- Participate in supplier evaluation processes reviewing and commenting on relevant documentation
- Participate in the review of Development/ Supply/ Quality Agreements and provide input
- Participate in the review of DHF documentation compiled by R&D Device Team
Requirements
What you’ll need- BSc/ MSc in Engineering, Chemistry, Pharmaceutical Sciences or another relevant sector
- Minimum 3 years of experience in Quality Management/ Assurance within the pharmaceutical industry preferred
- Good understanding of quality regulations ISO 9001, ISO 13485, and MDR will be considered an asset
- Fluency in English language (writing & speaking)
- Computer Literacy
- Ability to prioritize and meet deadlines
- Exceptional communication skills
- Strong project management skills
Benefits
Comp & perks- Involvement in a high-caliber, team-oriented and dynamic atmosphere
- Exposure to challenging business issues and practices
- Great opportunity to leverage and develop your business/ scientific knowledge and skills
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
quality management systemISO 13485EU MDR regulationUS-FDA 21 CFR Part 4US-FDA 21 CFR Part 820supplier auditsdocumentation developmentproject managementDHF documentationquality regulations
Soft Skills
communication skillsability to prioritizemeet deadlinesexceptional communicationstrong project management
Certifications
BSc in EngineeringMSc in EngineeringBSc in ChemistryMSc in ChemistryBSc in Pharmaceutical SciencesMSc in Pharmaceutical Sciences