Sr. Quality Engineer

ZipRecruiter; Manchester; On-site; GBP 45,000 - 75,000; Full time

Job summary

An innovative medical device manufacturer is seeking a Senior Quality Engineer to enhance manufacturing quality operations. This role involves ensuring compliance with industry standards, leading investigations, and driving improvements in a fast-paced environment. The ideal candidate will have a strong background in quality control within the medical device sector, showcasing leadership and project management skills. Join a dynamic team committed to delivering life-changing products and make a significant impact in the field of healthcare.

Qualifications

• 5+ years in Quality Control or Engineering role in medical device manufacturing.
• Experience with 21 CFR 820 and ISO 13485:2016 compliance.

Responsibilities

• Ensure products meet specifications and lead investigations of nonconformance.
• Participate in cross-functional teams for new product development.

Skills

Project Management

Leadership

Statistical Data Analysis

Critical Thinking

Technical Writing

Education

Bachelor's degree in Manufacturing

Mechanical Engineering

Life Sciences Discipline

Tools

Microsoft Office

Minitab

Job description

Job Description

Merrimack Manufacturing is a medical device manufacturer located in the Manchester Millyard. We are a growing manufacturing company that will play a crucial part in bringing innovative and life-changing products to life.

We are searching for a Senior Quality Engineer to support manufacturing quality operations in a dynamic, fast-paced, medical device manufacturing environment. This environment includes the manufacture, inspection, and testing of devices for design verification, design validation, and commercial production.

Duties & Responsibilities:

• Work under the direction of the Quality Manager to ensure all products, processes, and components meet specifications.
• Participate as a member of cross-functional teams to support new product development, commercial production, material-related design changes, manufacturing and process changes, risk management activities, and compliance projects.
• Ensure compliance with applicable standards and regulations such as 21 CFR 820 and ISO 13485:2016.
• Lead the Device History Records (DHR) review and approval process.
• Lead investigations of nonconformance reports (NCR) and CAPA activities.
• Develop and implement PFMEAs and control plans.
• Lead process and equipment validation activities (IQ, OQ, PQ/PV, TMV).
• Drive manufacturing and quality system improvements.
• Manage customer feedback processes and investigations.
• Author Engineering Change Orders (ECOs) and support their implementation.
• Apply engineering expertise to ensure compliance with standards and regulations.

Education:

Bachelor’s degree or equivalent experience in Manufacturing, Mechanical, or related engineering/life sciences discipline.

Experience:

• Minimum of 5 years of experience related to manufacturing of medical devices within a QMS environment, in a Quality Control or Engineering role.
• Experience with compliance to standards such as 21 CFR 820 and ISO 13485:2016.
• Proficiency with Microsoft Office (Word, Outlook, Excel).
• Experience participating in internal and external audits.

Knowledge & Skills:

• Strong project management, prioritization, and leadership skills.
• Ability to manage multiple priorities effectively.
• Experience with statistical data analysis tools like Minitab.
• Excellent presentation skills for meetings with peers and senior management.
• Critical thinking and deductive reasoning for risk-based decision making.
• Deep understanding of CAPAs, root cause analysis, and the 8D method.
• Excellent oral communication and technical writing skills.
• High attention to detail and accuracy.