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Senior Design Quality Engineer
Requisition ID: 1700210583W
DePuy Synthes Companies of Johnson & Johnson is the largest, most comprehensive orthopedic and neurological business in the world. DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials. Our broad array of inspired, innovative and high-quality offerings help advance the health and wellbeing of people around the world.
The qualified candidate for this hands-on position should excel in an environment that embraces change, risk and flexibility. This individual should be willing to make a visible contribution and therefore, be able to work independently.
POSITION DUTIES & RESPONSIBILITIES:
- Provide project direction, coaching, mentoring and supervision for quality engineering and technical team personnel.
- Lead and implement complex projects including quality improvement initiatives.
- Working knowledge of basic and advanced statistical methods (e.g., hypothesis testing, DOE, ANOVA, R&R studies, capability, tolerance interval analysis, power and sample size determinations, etc.).
- Demonstrate strong project management skills and lead cross-functional teams.
- Working knowledge of risk assessment tools (e.g., ISO 14971, FMEA’s, FTA).
- In-depth knowledge of quality engineering principles and methodologies.
- Working knowledge of process validation strategies (inclusive of I/O/P), software validation, design controls, CAPA, NC, etc.
- Provide leadership in understanding of the regulations to other disciplines.
- Support and lead product Design Control activities for new product development efforts.
- Conduct and lead Process/Design Validation activities and approach.
- Conduct Process/Design Failure Mode Effects and Analysis.
- Support Manufacturing Engineering in the creation of travelers, routers, bills of material, print changes, and specifications for in-house manufacturing.
- Conduct Internal Audits of the Quality System.
- Conduct audits of new suppliers as part of the project teams.
- Communicate effectively at all levels within Quality as well as cross functionally with departments such as PD, Regulatory, Sales, Supply Chain and Marketing in order to provide quality input.
- Additional duties as assigned.
- Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
- Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
PROFESSIONAL EXPERIENCE REQUIREMENTS:
- Strong quality engineering skills with a proven track record in process validation and failure mode effects and analysis is also required.
- A minimum BS degree in a technical discipline with 4-6 years of related experience for Quality Engineer
- 4-6 years of direct and/or related quality work experience in a regulated environment.
- Knowledge of the QSR and ISO9001/EN46001 quality requirements.
- Excellent problem solving and decision making skills.
- Interpersonal skills that foster conflict resolution as it relates to technical situations.
This job description does not constitute an employment agreement between the employee and DePuy Synthes Power Tools. The duties above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position. Duties of the job are subject to change as the needs of DePuy Synthes Power Tools and the requirements of the job change.
Synthes GmbH (7111)