Reporting to the Senior Manager, Quality Engineering for the Franklin Lakes design center, the Staff Quality Engineer II for the Wearable Injector platform primarily supports combination medical devices with complex electro-mechanical drug delivery systems. The associate is responsible for combining design control expertise, creative problem-solving approaches, and strong analytical skills to support new product development and product maintenance using quality engineering skills including but not limited to process validation, measurement system analysis, root cause analysis and design verification.
The position requires the ability to handle multiple projects, from product inception through product launch and maintenance. In addition, this position will play an active role in the processes to ensure products meet quality standards consistent with both corporate and unit policies, while meeting all design control and other regulatory requirements.
- Evaluation of customer requirements to identify applicable quality standards
- Release product during development activities
- Realization of quality functional reviews
- Assist/conduct Failure Investigations and problem-solving sessions for non-conforming products
- Consistent application of technical principles, theories, concepts and quality sciences / tools
- Assist in electro-mechanical hardware integration
- Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods, etc.
- Contributes to the completion of specific programs and projects
- Ensures quality conduct of projects, including design, data summary and interpretation and report generation for self and developers
- Collaborate with software engineers to develop requirements and perform hardware/ software integration
- Independently determines and develops approach to solution
- May provide guidance and work direction to other team members
- Designs and performs development working independently within defined parameters with minimal supervision required
- Liaise with Manufacturing Plants
- Provide functional support to cross-functional teams
- Define product control strategy
- Lead risk management activities
- Ensure design control elements are satisfied
- Ensure/ perform process validation activities
- Develop/ perform supplier qualification plans have been defined and completed
- Evaluate test methods used in project activities
- Ensure implementation of PS global procedures and standards for QE engineering activities
- Provide support to internal, regulatory body and customer audits and associated corrective actions.
- Develop systems, processes, and procedures related to project quality activities.
- Supports continuous improvement of current products and practices to improve quality, customer experience, and worldwide market share.
- Customer facing teams by providing technical support from a quality perspective.
- Ensuring the terms on the agreement are being met.
- Support drafting customer quality agreements
- Share risk mitigation strategies and control plans for the device with the customers as applicable.
Education & Experience:
Bachelor’s Degree in Engineering or other scientific discipline, with a minimum of 12 years relevant experience or a combination of equivalent education and experience.
- Thorough understanding of industry regulations/standards: ISO 13485, QSR, GMP, IEC 60601, EU MDR
- Knowledge of design control principles.
- Thorough understanding of statistical methods for Quality Assurance
- Experience in Quality System, Six Sigma Methodology, Validation, FMEA/Risk Management.
- Knowledge and experience in manufacturing, project management and engineering.
- Good written and oral communication skills
- Excellent problem solving and analytical skills
- Must possess excellent oral and written communication skills, and supervisory/leadership capability.
- Ability to handle multiple projects simultaneously in an unsupervised environment.
Very competitive salary and benefits!
Great company to work for!
Full relocation package is available!
Don't miss out! Apply now and we'll be in touch immediately with more specific details, salary information and to answer any questions!!
This position does NOT provide sponsorship so please do NOT apply if you require sponsorship. Thank You
KP Recruiting Group
"Bringing Talent to the Marketplace"
KP Recruiting Group is a well established and very respected recruiting firm. We have built a strong reputation as a premier resource for providing highly qualified candidates for our clients. We are very experienced in many industries and have a wide range of clients. We will serve as your advocate during your career search! Let us do the work for you! There is never a fee for our services!