Johnson & Johnson Karriere
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Design Quality Engineer
Requisition ID: 1700210597W
- Provide project direction, coaching, mentoring and supervision for quality engineering and technical team personnel.
- Lead and implement moderately complex projects including quality improvement initiatives.
- Working knowledge of basic 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.
- 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 2-4 years of related experience for Quality Engineer
- 2-4 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.
Synthes GmbH (7111)