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Quality Operational Manager
Quality System Manager
Medical Devices - German
Our client is a fast growing and innovative medical company.
- Acts as the key contact point for all QA ops processes
- Provides support to US team and EMEIA organization related to Quality Operational work and QMS processes development for 3rd party, suppliers and key project such as the one indicated above and related to the expansion of the EMEIA organization.
- Acts as the representative supporting EMEIA in terms of management, audit, contract review and define / execute the strategy to align internally all areas linked to RAQA for distributors management.
- Researches and assesses international medical device regulations, standards and guidance documents that could impact indirect markets liaising with the US team.
- Works with Ministries of Health and other Competent Authorities related to our EMEIA org when necessary and to back up the Senior RA manager to ensure that compliance interpretations are obtained, understood and appropriately communicated and documented in internal procedures.
- Works closely with cross-functional teams and individuals to provide regulatory guidance for new or already marketed products, manufacturing or other changes.
- Provides regulatory support to internal and external customers.
- Tracks and follows up estimated approval dates with all stakeholders within indirect markets and communicates effectively with marketing and sales.
- Management and support of EMEIA quality Operational processes, system process, support if needed in case of agency inspection at our facilities
- Develops and executes the RAQA management roadmap & Compliance expectation in key areas related to manufacturing, distribution, suppliers, etc .
- A Bachelor or Master's degree in engineering, medical technology or similar preferred (or equivalent work experience in similar function)
- 10 years of significant experience in quality manufacturing, regulatory affairs, quality system management in manufacturing or sales ops organizations in medical devices
- Solid understanding of manufacturing operations, change control, and an awareness of regulatory trends
- Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices. This includes analytical problem solving.
- Demonstrated organizational and planning skills, including action oriented, focused urgency and driving for results
- Ability to be effective in complex projects with ambiguity and/or rapid change
- Ability to handle multiple tasks and to prioritize and schedule work to meet business needs
- Excellent team skills with ability to collaborate, influence and lead others
- Good interpersonal skills, ability to work with others in team environment; effective interactions in cross department teams
- Team management experience of small team size associated with goals objectives definition / people development.
- Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook), experience with Agile a plus
- Detail orientated, with emphasis on accuracy and completeness
- Fluent in English and German (French will be a plus)
- Ability to travel 25% of his time
Preferred Knowledge, Skills, and Experience:
- Lead auditor certification for ISO 9001, 13485 and knowledge of WW regulations
- Good knowledge of reprocessing for refurbishment
- Project management skills regarding new site implementation / certification
- Could be located in Germany in our new German office
Great opportunity to join an expanding QARA team within a dynamic organization.