- Drive staff results by communicating job expectations, planning, monitoring and appraising job results, coaching and counseling employees, recognizing performance issues and driving improvement, developing, coordinating and enforcing systems, policies, procedures and productivity standards
- Establish strategic goals by gathering pertinent business, financial, service and operations information, choosing a course of action, defining objectives, and evaluating outcomes
- Maintain staff by recruiting, selecting, orienting and training employees; maintaining a safe, secure and legal work environment; developing personal growth opportunities
- Ensure validation program meets requirements of FDA (21 CFR Part 11 and Part 820), ISO 9001/13485, IEC 62304 and MDSAP.
- Identify differences between ISO and FDA requirements and their applicability to products targeting different markets
- Report broadly through the organization on validation activities and instrument manufacturing audit readiness
- Estimate timelines and budgeting for validation engineering development efforts
- Formalize, standardize and document processes
- Assist development and manufacturing engineering in designing, performing, and improving verification tests
- Participate as an active member on new product development teams
- Interact with cross-disciplinary project teams in order to meet project milestones and end goals
- Work with scientists, technicians, engineers, marketing, and project management to deliver commercial and internal genetic analysis systems
- May lead cross-functional teams to address system issues
- 5-7 years managing a mid-size (6-10 FTE) team with demonstrated ability to coach, mentor, develop and discipline
- Experience in the medical device/IVD industry in the development and deployment of Quality Systems, process controls, and continuous improvement methods.
- Experience in both front room and back room audit support.
- 5-7 years experience in manufacturing, quality assurance or engineering in an FDA regulated environment.
- Knowledge and working application of FDA (21 CFR Part 11 and Part 820), ISO 9001/13485, IEC 62304 and MDSAP requirements.
- Knowledge and working application of Validation Principles, guidelines and industry practice.
- Proven ability to lead in a continuous improvement environment, identify the end state and lay out a step-by-step plan for attainment while messaging broadly achievable timelines.
- Knowledge and working application of FMEA and Risk Analysis.
- Demonstrated strong analytical problem solving (CAPA)
- Solid understanding of manufacturing processes in medical device manufacturing
- Strong verbal and written communication skills are required.
- Experience supporting the transition of an RUO manufacturing line to Dx/IVD control a strong plus.
- Experience with statistics, Statistical Process Control and DOE techniques is a plus.
- The ability to discuss technical topics with non-technical people is strongly desired.
- Six SigmaBlack Belt certification, PMP certification, ASQ accreditations a plus.
• Requires a Bachelor, Masters or PhD. degree in engineering or science and a minimum of 12years of related experience.