Address
Form of workJob Description
Senior Quality Engineer
This is an exciting role that will work with the quality assurance, quality control, and operations team to ensure that products are manufactured safely with the highest level of quality promptly that meets or exceeds customer and regulatory requirements. They are headquartered in the Totowa, NJ area. The company is a leading manufacturer and supplier of medical devices. If you are an individual who loves to lead quality processes and is passionate about the medical device industry, this role could be for you!
Responsibilities:
- Work with the operations and the business teams to ensure quality performance of products and processes.
- Oversight and approval of Nonconformity (NC) and Corrective and Preventive Actions (CAPA).
- Contribute and lead the improvement and development of the manufacturing processes for existing and new products.
- Develop and provide input for risk management by identifying opportunities and weaknesses.
- Responsible for review and approval of process and equipment validation and qualification.
- Analyze and review concession requests.
- Review and approve change management activities as necessary.
- Maintain KPI for monitoring process quality, interpreting trends, and performing analysis.
- Proficient in risk management practices and tools, having high expertise in process risk.
- Proficiency in and makes continuous strides towards optimization of inspection methods and sampling.
- Support First Article Inspections.
- Participate in internal and external audits with regulatory representatives.
- Responsible for initiation, management, and support of Ship, Product Holds, potential product escapes.
- Coach and mentor junior engineers in quality topics and responsibilities.
Qualifications:
- A minimum of 2-3 years of relevant experience in the manufacturing industry or a Master’s degree in engineering or a relevant scientific discipline is required.
- Bachelor’s degree in engineering or a relevant scientific field is required.
- Must have excellent communication skills and work well with a team.
- Previous experience with lean tools is preferred.
- Previous experience with the medical device industry is preferred.
- Proficiency in statistical methods and root cause analysis.
Salary Range:
- $80,000-120,000 depending on experience.
