Ensure Stryker GmbH is in a state of regulatory compliance by leading the Quality organization including the division’s Design Quality Assurance Engineering function and the Quality System Management function.
Responsibilitiesand duties
• Ensure divisional achievement of quality, regulatory and compliance targets.
• Provide a strategic direction and tactical focus to the Quality Assurance organization; manage the functional QA activities
• Oversee effective utilization and understanding of Quality Assurance systems in our regulated environment.
• Serve as alternate management representative in the absence of Vice President, CQR.
Qualifications/Work Experience Preferred
•10-15 years related experience in a quality and regulatory for medical or pharmaceutical.
• 7-10 years of supervisory/management experience recommended
• Applied knowledge of regulatory requirements, including ISO 9001, ISO 13485, Quality System Regulation and EU Medical Device Directive and EU medical device regulation
• Applied knowledge and demonstrated ability to effectively utilize quality tools such as FMEA, Root Cause Analysis
• Demonstrated ability to manage complex projects
• Demonstrated ability to manage people in a multi-discipline, multi-technology, team-based organization.
• Demonstrated verbal, written and interpersonal skills
• Demonstrated ability to work in a team environment and to interact effectively with management from other internal/external functions
• Preferred candidate will have experience working in a multinational environment.
• Fluency in English is essential; knowledge of a second European language is recommended.
• Demonstrated success in creating a strategies to lead a team to success
• Considerable personal experience presenting, interacting, and building effective relationships with regulatory agencies
• Excellent communication and presentation skills (articulate and persuasive)
• Pro-active, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships with medical professionals
• Teaches and coaches others in technical and leadership areas.
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