This Quality System (QS) Manager is responsible for the leadership and oversight of the Quality Management System which will consist of the following quality system elements: Quality System Management Review (QSMR), CAPA system management, Quality Planning, Quality Metrics, Intra Company Quality Agreement Management, External Standard Management, and Training.
- Provide daily leadership and management for the Quality System team.
- Establish, maintain, and improve the Quality System procedures and processes.
- Act as QS subject matter expert and resource leader for Quality Assurance to deliver results.
- Work in a cross-functional environment to identify process and system improvements to enhance efficiency and improve process performance while maintaining compliance.
- Lead, influence, and negotiate to achieve business strategies and deliver results on time.
- Develop and implement measures and metrics to monitor QS and present to executive management.
- Lead Quality System Management Reviews to ensure QS is suitable, adequate, and effective.
- Provide leadership and oversight of the CAPA system and sub-processes.
- Establish, maintain and implement Quality System training to the entire organization including a system to maintain training records.
- Develop annual quality plans and objectives and ensure commitments are met and effective.
- Serve as technical expert of QS, Management Controls for the organization.
- Represent QS, Management Controls during regulatory inspections and notified body audit.
- Provide inspection support; inspection readiness, execution (front room and back room) and post inspection activities.
- 5 Years, experience in medical device, pharmaceutical, or other regulated industry is required
- 3 Years, experience in quality assurance in regulated industry; Medical Device is preferred
- 2 Years, experience in management is preferred
Bachelor of Art or Science Degree, Preferred degree in Engineering, Life Sciences, or Physical Sciences
KNOWLEDGE, SKILLS & COMPETENCIES:
- Knowledge of 21 CFR Part 820, ISO 13485, MDSAP, MDD/ EU MDR
- Experience in quality systems within medical device or pharmaceutical industry
- Experience in training, management reviews, and QS metrics
- Experience supporting regulatory inspections and audits (i.e. FDA or Notified Body)
- Experience in computerized quality management systems (i.e. Trackwise, EtQ, Compliancewire, Mastercontrol)
- Experience in Microsoft Office (i.e. Word, Excel, PowerPoint)
- Ability to work in a self-directed environment and team environment
- Ability to influence across functional areas and make change
- Skilled project manager and change management
- Critical thinker, detailed oriented, organized, and collaborative
- Excellent written and oral communication skills
- Strong leadership and coaching skills
TRAVEL / PHYSICAL DEMANDS:
- Travel typically less than 20%. Office and factory environment.
- Job demands may require long periods of sitting, standing, telephone work, computer work
- Job demands may require may require occasional bending, kneeling, stooping and lifting up to 25 pounds
Job Type: Full-time
- management: 2 years (Required)
- Quality Assurance (medical Device preferred): 5 years (Required)
- medical device or related: 5 years (Required)
- Health insurance
- Dental insurance
- Vision insurance
- Retirement plan
- Paid time off