NPI Quality Engineer

ZipRecruiter; Manchester; On-site; GBP 40,000 - 55,000; Full time

Job summary

A leading company in medical device manufacturing is seeking an NPI Quality Engineer to enhance quality operations and support design transfer activities. The role involves leading improvement projects, ensuring compliance with regulatory standards, and developing quality documentation. Ideal candidates will have a degree and relevant experience in regulated industries, along with strong problem-solving and project management skills.

Qualifications

• At least 3 years of experience in Medical Device Manufacturing or regulated industry.
• Strong knowledge of CFR Part 820 and ISO 13485 standards.

Responsibilities

• Evaluate new products and ensure compliance with regulatory standards.
• Lead project teams through validation protocol development and execution.
• Conduct investigations resulting in root cause analysis.

Skills

Problem Solving

Communication

Project Management

Education

B.A. or B.S. degree

Job description

Job Description

Merrimack Manufacturing is seeking an NPI Quality Engineer to support design transfer activities and quality operations in an innovative, fast-paced medical device manufacturing environment. This role includes maintenance of control plans, risk management files, validation protocols, and other QMS documentation to support initial qualification and launch of commercial production activity. The role will also provide support to organizational goals by leading improvement projects to increase efficiency and compliance across the site.

How you will make an impact:

1. Leverage your engineering and technical experience to evaluate new products, manufacturing processes, and ensure compliance with applicable regulatory standards throughout the New Product Introduction process.
2. Provide input to the development, review, and update of User Requirements, critical quality attributes, and other design documentation.
3. Lead project teams through validation protocol development, execution, documentation organization, report writing, etc., while meeting schedules for final approval and release for use.
4. Conduct investigations resulting in root cause analysis and corrective actions through data analysis, inductive and deductive reasoning, and problem-solving skills.
5. Lead the evaluation and identification of validation requirements and sampling plans for new and modified manufacturing processes, test methods, and equipment.
6. Develop inspection procedures and sampling plans for new production, continuous process improvements, and workflow enhancements.
7. Assist in developing, implementing, and approving Device Master Records, Device History Records, and Risk Management Files for new products.
8. Provide guidance on assessing new and modified manufacturing equipment, ensuring proper enrollment into QMS systems and validation requirements are met.
9. Lead improvement projects to increase efficiency and compliance within Merrimack Manufacturing’s Quality Management System.
10. Contain defective products and processes systematically, participate in Material Review Board (MRB) meetings, and track nonconformance investigations.
11. Support external audits by regulatory bodies or customers, contributing to successful outcomes.

To be successful in this role, you will need the following skills and experience:

1. B.A. or B.S. degree; relevant technical experience may be considered in lieu of formal education.
2. At least 3 years of experience in Medical Device Manufacturing or a similarly regulated industry such as Aerospace or Military.
3. Strong knowledge of CFR Part 820 and ISO 13485 standards.
4. Lean or Six Sigma certification.
5. Knowledge of IQ/OQ/PQ requirements, measurement system analysis, and engineering specifications.
6. Experience with Design Transfer and new product process introduction.
7. Strong understanding of tolerance stack-up calculations and calibration practices.
8. Excellent organization, communication, and time management skills; project management experience.
9. Knowledge of industry standards and best practices for Software Validation, Controlled Environments, Biocontamination Controls, and Gamma Irradiation.