Senior Manager, Quality Assurance, Medical Device
Ability to work for a leading global manufacturer of medical devices!
Strong career progression with a company that is growing exponentially!
About Our Client
My client is a medical device manufacturing leader, developing, manufacturing, and marketing proprietary biological testing technologies that have various applications throughout the life sciences industry. They are looking for a Senior Manager of Quality Assurance to lead, establish, implement, and maintain quality assurance systems both domestically and internationally for commercial medical devices, designed, produced, and marketed by my client.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
- Manages, leads and mentors Quality Assurance department and personnel
- Site Management Representative - liaison between staff and top management, assure maintenance and effectiveness of quality system and operation, ensure certification remains intact, escort for external audits
- Promotes, mentors and coaches staff for growth
- QA lead in Risk Management activities, including responses to complaints and recalls
- Quality lead in product development team meetings, technical design reviews, and phase gate design review meetings to ensure quality assurance requirements are met.
- Integral member of new product development teams. Responsible for ensuring compliance during the design control and design transfer process
- Regularly reviews quality system standard operating procedures and work instructions, making changes as necessary to ensure compliant and efficient Quality Assurance processes.
- Provides input to the Management Review and Quality Review Board processes and monitors the Quality Management System (QMS), and provides training throughout the organization
- Responds to identified and potential nonconformities, complaints, deviations, and corrective/preventative actions assigned to Quality Assurance
- Participates in Audits - internal and external, as SME or escort
- Key member of Review Boards as per Quality processes (e.g., MRB, CRT, ORB, SRB)
- Responsible for all aspects of regulatory compliance and regulations
The Successful Applicant
- Bachelor's Degree Bachelor degree required, in a life science or engineering discipline preferred OR minimum 8 years' work experience in a regulated / medical device industry required OR Demonstrated knowledge of current industry quality practices under ISO 13485, ISO 14971 preferred
- Management experience in a complex quality assurance/quality systems field preferred
- Ability to provide leadership to others in the organization through influence, innovative practices and coaching skills to foster a corporate culture of responsiveness, compliance awareness, self-regulation, quality system ownership, challenge of status quo, and continuous improvement in order to achieve the highest level of compliance
- Possesses a strong scientific and technical background
- Excellent problem solving methodology, using industry accepted concepts and tools to solve complex problems in creative and effective ways as they apply to compliance issues
- Hands-on ability to sort through technical complexities and work in a flexible changing environment
- Thorough knowledge of standards and regulations (cGMP, ISO 13485)
- Certification in a quality discipline preferred such as CQM, CQA
What's on Offer
- Exceptional career progression opportunities
- Competitive base salary + bonus
- Strong benefits