Quality Engineer, Medical Device
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Bullet points
Ability to work for a leading global manufacturer of medical devices!
Strong career progression with a company that is growing exponentially!
About Our Client
This company is a global manufacturer of specialty medical products and devices across a broad line of medical specialties with facilities across the US. They are looking for a talented Senior Quality Engineer to add to their growing team.
Job Description
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
Description
The Senior Quality Engineer will be responsible for developing and maintaining quality engineering methodologies and providing quality engineering support with new product development, manufacturing or system/services support teams. This individual will identify and implement effective process control systems to meet or exceed both internal and external requirements. This role's responsibility will be to lead the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal or external requirements.
The Senior Quality Engineer will assist in the development and execution of streamlined business systems issues applying systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. This individual will design and conduct experiments for process optimization and improvements, ensuring that appropriate document experiment plans and results, including protocol writing and reports, are added to the company's EQMS, as well as participate in or lead teams in supporting quality disciplines, decisions, and practices.
The Senior Quality Engineer will manage process control and monitor CTQ parameters and specifications and will work to implement various product and process improvement methodologies (Six Sigma, Lean Manufacturing). This quality professional will provide solutions to a wide range of difficult problems relating to the quality and regulatory aspects of design, validation, and manufacturing of Class I (and higher) medical products. They will serve as the owner and administrator of several aspects of the quality system, including to but not limited to supplier management, process control, statistical techniques, and design control.
The Successful Applicant
- BS degree in Engineering or Technical Field or equivalent experience
- 5 years of experience as a Quality Engineer
- Experience with FMEA and Risk Assessment as they pertain to product development
- Engineering experience and demonstrated the use of Quality tools/methodologies
- Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
- Strong project and time management skills, including the demonstrated ability to work in multi-departmental project teams and resolve quality-related issues in a timely and effective manner
What's on Offer
- Competitive salary range: $90,000-105,000/year
- 7% annual bonus (dependent on company discretion)
- PTO: up to 8 Holidays and 2 weeks of vacation
- Medical, dental benefits
- 401(k)
- Paid professional training ECUs
- Opportunity for growth vertically dependent upon company opportunity and performance reviews