- Direct and coordinate major quality projects provide significant guidance and approval regarding technical strategies and approaches.
- Develop and monitor department budgets to maximize investments, increase efficiencies and ensure the quality of our product.
- Drive the development of department tools and methodologies.
- Establish long-range objectives and specifying the strategies and actions to achieve them (i.e. develop policies, procedures, methods, and/or standards).
- Manage staff, preparing work schedules and assigning specific duties and tasks.
- Coaching and developing your team - identifying the developmental needs of others and coaching, mentoring, or otherwise assisting/helping others to improve their knowledge, skills, attaining career goals.
- Motivates individuals to achieve results, and recruits and maintains a high quality team.
- Ensures processes needed for the QMS are established, implemented, and maintained.
- Management Review
- Supplier Quality / SCAR
- Calibration
- Non-conformance
- Document Control
- CAPA
- External QMS Audits (Customer; Notified Bodies)
- Corporate Internal QMS Audits
- In-process Inspection/Other duties and assignments as directed by Management
- Degree in related discipline and 5+ years experience in Medical Device / ISO13485 environment
- cGMP/cGDP Experience (preferred)
- Six Sigma Certification (preferred)
- ASQ CQE Certification (preferred)
- Quality Engineering (i.e. DOE, Inference Tests, Normality/Capability Analyses, Correlation Studies, Gage RR, etc.)
- Information Analysis (Mini-Tab experience preferred)
- Excellent organizational and oral/written communication skills.
- Strong work ethic.
- Maintain a positive work atmosphere by behaving and communicating in a manner that fosters a professional environment for clients and associates.
- Able to interface effectively at all levels and communicate effectivity as part of a team.
- Strong sense of urgency.
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Quality Manager - Winston-Salem, United States - Connect Life Science
Description
Quality Manager
Full-time Permanent Position
$110,000 - $125,000
Medical Device Manufacturing
Winston-Salem, NC
Overview:
Our client is seeking an experienced Quality Manager for a brand new facility within an established ISO 13485 regulated company. They are building a brand new, world class facility in Winston. You will be responsible for creating, developing and shaping the future of the quality team. Its a fantastic opportunity to take control of a project and further your career.
The role:
Youll manage the following functions and tasks directly or through the team:
Education and/or Experience:
Skills and Abilities
Interviews happening in ASAP in May for June start date Apply early with up-to-date CV for a call back