Quality Engineer

Merrimack Manufacturing

Manchester, NH

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JOB DETAILS

JOB TYPE

Full-time

SKILLS

Biology, Code of Federal Regulations, Continuous Improvement, Corrective Action, Data Analysis, Data Collection, Deductive Reasoning, Design Verification, Documentation Plan, External Audit, FDA Requirements, ISO (International Organization for Standardization), Inductive Logic, Internal Audit, Maintain Compliance, Manufacturing, Manufacturing Operations, Mechanical Engineering, Medical Equipment, Microsoft Excel, Microsoft Office, Microsoft Outlook, Microsoft Word, Operational Support, People Management, Problem Solving Skills, Process Development, Process Improvement, Product Support, Quality Assurance Methodology, Quality Control, Quality Engineering, Regulations, Regulatory Compliance, Reliability Analysis, Risk, Root Cause Analysis, Sampling Inspection, Six Sigma, Statistics, Team Player, Technical Writing, Testing, Validation Plan, Validation Testing

LOCATION

Manchester, NH

POSTED

7 days ago

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.

About the Company

Merrimack Manufacturing

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