Design Quality Engineer

Job Description

We are hiring a fulltime Quality Engineer with experience in medical device design quality and risk management to support product development from concept through commercialization. This role will primarily support R&D and Process Engineering activities to ensure compliance with design controls and risk management requirements.

The ideal candidate must have hands-on experience with design controls and risk management, including FMEA and structured problem-solving methodologies, and a solid understanding of ISO 13485, 21 CFR 820, and ISO 14971 requirements to identify and mitigate potential compliance, product and patient safety risks.

Objective

The objective of this position is to provide the level of resource necessary to maintain, monitor and improve the Quality Management System (QMS), to ensure compliance with regulatory requirements and established local and corporate practices.

Responsibilities and Essential Functions - Engineer II, Quality:

• Responsible for, at a minimum, one critical functional area of the Quality Management System (QMS) (e.g., CAPA, NCR, Deviations, etc.).
• Identify and implement activities geared to standardize and streamline quality practices across the organization to improve QMS efficiency and maintain its effectiveness.
• Lead and provide guidance to the rest of the organization in proper root cause investigation techniques.
• Provide guidance on the use of statistical techniques for selection of sampling strategies and analysis of data.
• Facilitate CRB, QRB, and Management Review meetings.
• Responsible for data trending and preparation for Management Reviews and Corporate Management Reviews.
• Write and execute Test Method Validation (TMV) documentation related to Quality Assurance inspection methods, as necessary.

Qualifications:

• Bachelor’s degree in Engineering or technical field equivalent experience.
• 2 - 5 years of experience working in quality and/or quality engineering roles. Within the medical device manufacturing industry is preferred.
• Working technical knowledge and application of quality concepts, practices, and procedures.

Required skills:

• Experience with ISO 13485 and/or 21 CFR Part 820.
• Good attention to detail and organizational skills.
• Proficient at applying analytical and problem-solving tools and methodologies.
• Ability to work, interact, and communicate effectively with others.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.

Pay:

$70,000.00 - $100,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Work Location:

In person