Principal Design Quality Engineer - KMC REF1877K

Job Description

The Principle Design Quality Engineer will work as a member of a cross-functional project team engaged in new product development.

The individual will serve as a quality representative on development projects and will work closely with Engineering, Manufacturing, System Engineering, Software Engineering, and Project Management.

This individual will be responsible for ensuring that the product development project is executed and released meeting customer expectations, regulatory requirements, appropriate standards and company policies and procedures.

This role will be a key member of the product development team and will have the opportunity to influence the product design direction based on the customer needs and product reliability expectations and performance.

PRINCIPAL RESPONSIBILITIES

In this position, the candidate will lead or participate in the following :

• Serve as a quality representative on project teams engaged in new product development of medical devices;
• Support design and development planning, development of design input and design output activities, risk management activities, Design History File management, design transfer activities, change management and design reviews;
• Lead Quality Assurance programs and ensure plans are in place to provide and maintain the quality levels for assigned projects in accordance with contract requirements and product specifications.

Assure the compliance of engineering and manufacturing program documents (good documentation practices).

• Ensure products are developed and released that meet customer expectations and regulatory requirements including 21CFR, ISO , and ISO .
• Review and approve design verification and design validation documentation, risk management documentation, product documentation, specifications, and drawings for medical devices;
• Support process development, test method development, and associated validation activities;
• Use statistical tools and techniques to analyze and evaluate trends, investigate failures, determine root cause and take appropriate corrective actions to prevent recurrence where appropriate;
• Oversee qualification and testing requirements, initiate required customer reports and lead / support corrective action efforts on failures / defects.
• Facilitate integration of new products into manufacturing.
• Provide technical support for supplier selection and supplier evaluations. Work with Quality, Engineering, and Manufacturing to assess the supplier's ability to meet designated specifications and develop quality control plans where needed;
• Ensure company policies, procedures, practices and facilities comply with all applicable customer and regulatory requirements;
• Any other emerging quality related duties as identified and assigned.

Qualifications

• BS degree in Engineering, Biomedical Engineering, Computer Science, or other technical fields.
• 8 years minimum of related experience in the application of design controls and risk management in the IVD or Medical device industries.
• Strong knowledge of Quality Systems, Design Controls, 21CFR, 21 CFR Part 11, ISO , ISO , IEC , IEC , IEC and applicable medical device regulations.
• Strong, demonstrated ability to think out of the box to provide technically sound Quality Assurance and Quality System solutions to designated programs to achieve business results and maintain high levels of quality and compliance.
• Ability to assess, make critical decisions, and articulate risk when evaluating a situation.
• Proficiency in risk management techniques and experience leading others through process mapping exercises and coaching others in problem solving is desired.
• Demonstrated experience working with contract manufacturing, suppliers and customers.
• Excellent communication, problem solving, organizational and interpersonal skills are required.
• Green Belt, Lean, Black Belt proficiency is desired.
• Professional certifications (CQE, CQA, CRE) are desired.
28 days ago