Medical Devices Quality Engineer

Medical Devices Quality Engineer Job Highlights

Company Profile

Specialty Resources is a global sourcing and inventory management company for precision components and specialty products. The company’s domestic and offshore partnered factories allow it to source and supply customers with quality products at competitive prices. SRI can supply precision machined components, stampings, bearings, castings/forgings, cold-headed/powdered metal parts, electrical components, rubber/plastics, seals, gaskets, springs, sheet metal fabrication, and fasteners.

Job Profile

The company is seeking a Medical Devices Quality Engineer who will help lead Specialty Resources’ expansion into the Medical Devices industry while supporting SRI’s principles of and commitment to continual improvement.

This position supports all department activity with a focus on QMS compliance and further development into the Medical Devices industry.

Educational Qualification

• The applicants should have completed a Bachelor of Science in Mechanical Engineering or other engineering disciplines from a college/university.

Work Experience

• The candidates should have a minimum of 5 years of experience in quality control, assurance, and engineering environment.
• Experience with Inspection Metrology, GD&T, MSA, manufacturing processes, and engineering drawings
• ISO13485 Medical Device Manufacturing experience.
• Machine Shop and Manufacturing Factory environment experience

Duties/Responsibilities

• Champion activity to resolve customer product complaints and issues related to nonconformances.
• Coordinates factory process Validation activity as required.
• Lead and mentor factory team’s development of their QMS to align with FDA & SRI requirements.
• Lead in the house and factory problem-solving / troubleshooting activity to resolve issues and implement improvement actions for effective long-term problem elimination and increased manufacturing efficiency.
• Lead Quality System enhancements to meet applicable FDA requirements.
• Performs and conducts problem investigations using CAPA processes and RCA tools and methodologies.
• Provide structure, discipline, and training to assure manufacturing and quality systems provide repeatable control, are appropriate, adequate, and practiced. Provides audits to assure long-term compliance.
• Supports the generation of PPAP documentation such as Control Plans, Process Flow Maps, FMEA, Inspection plans and techniques, GR&R & test requirements.
• Supports training and department growth as requested by department leadership.
• Track and evaluate factory performance to determine the action required for development and improvement.
• Travel to factories when necessary, (APAC region and where required), to support production and supply base development, including factory assessment, audits, training, and improvement follow-up.

Preferred Qualifications

• ASQ certification(s)
• Complaint Handling experience
• Experience with a variety of component manufacturing, production, and qualification and validation test processes related to machining, welding casting, molding, stamping, forging, painting, plating, heat treating, assembly, and fabrication.
• ISO 13485 / MDD / FDA knowledge and experience
• ISO 13485 manufacturing environment experience
• Mechanical aptitude for working with tools to perform assembly and testing of a product.
• PPAP, CAPA, RCCA, 8D, DMAIC, PDCA, SPC, GD&T, LSS, ISO 13485, ISO 9001, and Lean Manufacturing trained and experience
• Process Validation experience and involvement

Skills/Knowledge/Abilities

• Knowledge of and first-hand experience with FDA/ISO Regulations

Benefits/Perks

• The company offers a comprehensive benefits package including PTO, Medical, Dental, Vision, and 401(k).

Other Requirements

• Has (or has the ability to obtain) a current passport and is agreeable to occasional domestic/global travel.

Employer’s Statement

Specialty Resources is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, or national origin.

Note: Employees are carefully selected based on positive work history, reference verification, and background checks.