Quality Engineer

Merrimack Manufacturing; Manchester (NH); On-site; USD 65,000 - 90,000; Full time

Job summary

Merrimack Manufacturing in Manchester, NH seeks a Quality Engineer to support manufacturing quality operations in a fast-paced medical device environment, including design verification, inspection, and production testing.

You will drive PFMEAs, control plans, sampling methods, and CAPAs, participate in ISO 13485 audits, and work with customers to resolve nonconformances using Six Sigma tools and data analysis.

Qualifications

• 3+ years in Quality Control for medical devices.
• Experience with 21 CFR 820 and ISO 13485:2016.
• Experience participating in internal and external audits.

Responsibilities

• Support manufacturing quality operations in a fast-paced medical device environment.
• Transition products from development to manufacturing per standards (21 CFR 820, ISO 13485).
• Develop and approve PFMEAs and control plans.
• Develop inspection processes and sampling plans by risk level.
• Contribute to Device Master Records and Device History Records.
• Lead root-cause investigations and CAPA using data analysis.

Skills

Quality control

Regulatory compliance

Audits

Education

Bachelor’s degree or equivalent (Industrial/Mechanical/Life sciences)

Tools

Six Sigma

Job description

COMPANY OVERVIEW

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.

POSITION OVERVIEW

This position will support manufacturing quality operations in a dynamic, fast-paced, medical device manufacturing environment. This environment includes the manufacture, inspection, and test of devices for design verification, design validation, and commercial production.

RESPONSIBILITIES

• Work cooperatively with other team members and in compliance with applicable standards and regulations such as 21 CFR 820 and ISO 13485:2016 to transition products from development to manufacturing.
• Use experience within medical devices, to provide guidance and assistance in the development of new production processes
• Drive the development, implementation, and approval of PFMEAs and control plans.
• Develop inspection processes and sampling plans according to the risk level of the components, material and devices
• Use experience with engineering and technology to ensure compliance with applicable standards and regulations.
• Ensure all product, processes, and components are within specifications and work with internal team and with customers to resolve any nonconformance issues
• Facilitate the development, implementation, and approval of Device Master Records and Device History Records.
• Review existing procedures and for continuous improvement and improved workflow
• Lead investigations resulting in root cause and corrective actions through use of data analysis, inductive and deductive reasoning, and problem solving skills.
• Use critical thinking and deductive reasoning to make risk based decisions.
• Develop and approve technical documents to plan work, such as Master Validation Plans, Quality Plans, and Qualification Protocols; support execution of work product.
• Collect and evaluate data, lead system and process improvements using six sigma tools
• Provide reliability and statistical analysis of data for investigations, qualifications, test method validations and other Quality related activities.
• Participate in ISO 13485 audits and assist in FDA and other regulatory inspections. Will use Microsoft Office software (Word, Outlook, Excel).

QUALIFICATIONS AND SKILLS

• 3 + years of experience in occupation related to Quality Control of medical devices.
• Experience with compliance, with applicable standards and regulations such as 21 CFR 820 and ISO 13485:2016 is required.
• Experience participating in internal and external audits.

EDUCATION

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