Job Description Summary
Manages and develops the Quality Assurance Department. Provides Quality Engineering leadership to support Operations and to drive Continuous Improvement. Assures compliance to procedures and requirements. Identifies and implements QA initiatives for Operational continuous improvement and product support. The Quality Assurance Manager is the Deputy Management Representative for the Site.
- Manages QA department and overall expectations pertaining to setting accurate schedules, costs and resources.
- Ensures department is adequately resourced and trained to perform jobs effectively.
- Directly supervises QA staff including coaching and developing to enable maximum performance and individual employee growth, providing regular performance review and feedback and using corrective action as necessary.
- Ensures delivery against QA department goals and objectives, i.e. meeting commitments and coordinating overall quality assurance schedule.
- Encourages a team atmosphere and leads by example.
- Serves as a team member to provide quality engineering expertise to continuous improvement teams and manufacturing support.
- Implements ongoing quality improvement processes working with interdepartmental teams.
- Develops project schedules and resource allocation models for QA related projects and other activities to support Project Teams.
- Provides effective communication regarding issues, objectives, initiatives and performance to plan.
- Develops inspection and process control procedures, process through document control and provides training for the procedures.
- Develops metrics to identify and prioritize activities pertinent to process control, risk reduction, and cost improvement.
- Facilitates communication and teamwork between R&D/NPD and Operations, towards the purpose of Design Transfer.
- Maintains Company compliance of FDA Quality System Regulations and ISO:13485 standards.
- Performs special projects and other duties as assigned.
- Bachelor's to advanced degree in Engineering, Quality Assurance or related discipline.
- Minimum of ten (10) years' experience in quality engineering with medical device and/or pharmaceutical manufacturing(combined experience preferred), to include at least two (2) years recent supervisory experience developing direct reports.
- Experience in root cause investigation.
- Managing external audits (FDA, Notified Body, MDSAP).
- ASQ CQE certification preferred.
- Must have DOE, Statistical Analysis, Quality System implementation (CAPA, NCR, Complaints), Quality Engineering Techniques, IQ/OQ/PQ, QSR (GMP) and current ISO 13485 experience.
- Excellent problem solving, interpersonal communication, presentation, statistical analytical, computer, and project management skills.
- Must have a positive attitude with excellent communication, negotiation and interpersonal skills to maintain a team-oriented environment and maintain critical relationships with contractors, suppliers and investors.
- Ability to lead, train, monitor, mentor and coach inspectors, and technicians.
- Ability to thrive under challenging deadlines and in an energetic environment.
- Must have a desire for achieving excellence in customer satisfaction, process and product quality and reliability.
Primary Work LocationUSA CA - Irvine Neomend