Quality Engineer III (Healthcare)

POSITION SUMMARY:

• This position is accountable for development, implementation, evaluation, and support of New Product Development (NPD) activities for their assigned plant.
• Leads major programs from a quality assurance standpoint through the applicable phases of the product development process.

ESSENTIAL DUTIES:

• Lead improvement of the Product Development Process to ensure regulatory requirements like 21 CFR Part 820, MDSAP, ISO 13495, EU MDR, MDD are met, and that the medical device meets the requirements for its intended use
• Lead NPD validation efforts which include creation, coordination and execution of protocols for Test Method Validations (TMVs), Installation Qualification (IQ), Operational Qualification (OQ) and Process Qualification (PQ)
• Applies the Risk Management Policy to the development process for identifying hazards, estimating and evaluating associated risks, controlling these risks and monitoring the effectiveness of risk controls
• Able to navigate completely new medical devices through product requirements, design inputs, design outputs, customer requirements and verification/validation in traceability matrix
• Responsible for owning and maintaining Risk Management File, dFMEA, pFMEA (design/process Failure Mode Effects Analysis) and Control Plans
• Participate in customer engagements, customer complaints and NCR investigations and other problem-solving efforts.  Assist in measuring/collecting product and process data/information necessary to determine or validate root causes and permanent corrective actions.
• Implements corrective actions and uses CAPA system to consistently improve product quality.
• Programming optical/vision-based measurement systems like MicroVu, Keyence etc. for new products and validating the measurement method
• Collaborate with Engineering to design and manufacture fixtures and other work holding devices for the measurement process and develop efficient, scalable, automated measurement processes
• Implement Statistical Process Control (SPC) for new processes, perform First Article Inspection (FAI) and improve First Pass Yield (FPY)
• Lead process automations like paperwork reduction, Quality 4.0 initiatives, Electronic QMS implementation.
• Utilizing lean and six sigma tools to improve internal manufacturing and non-manufacturing processes.
• Understands all aspects of assigned production line(s) to help minimize scrap and complaints.
• Prepares written protocols and reports.
• Mentor junior level team members.
• May lead and direct the work of others in various projects and assignments.

• Performs other duties as required.

QUALIFICATIONS (Education/Experience/Knowledge, Skills & Abilities)

Required:

• Bachelor's degree or higher in Engineering (Mechanical/Industrial/Engineering Management/Biomedical/Electrical)
• 7 + years of industry experience in a similar role
• Has knowledge of commonly used concepts, practices, and procedures within the field, including regulatory affairs.
• High degree of understanding of ISO 13485, MDSAP requirements for Design Controls
• Ability to problem solve, identify errors and deficiencies and perform research independently
• Ability to apply knowledge to their job function using pre-established guidelines and instructions
• Accuracy, attention to detail, and thoroughness
• Proficient in computer skills and ability to use MS office, Minitab etc.
• Proficient communications skills
• Ability to comprehend and comply with company safety and quality standards
• Ability to follow oral and written instructions
• Responsible for understanding and complying with all SPG and Dupont safety policies and procedures.

Preferred:

• Master's degree in engineering discipline
• Previous experience in Quality Assurance
• Advanced knowledge of statistics
• Medical device experience
• Certified Quality Engineer (CQE) and ISO 13485 Lead Auditor Certification
• Lean Six Sigma Green Belt or Black Belt

WORKING CONDITIONS:

This position requires about 50% of time spent sitting and working on computer.  The other 50% of time would be spent moving around on the Production floor where protective clothing is necessary.