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Quality Engineer
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Merrimack Manufacturing Manchester, United StatesMerrimack 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 Quality Engineer to support manuf ...
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Quality Engineer
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Quality Engineer
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Quality Engineer
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Quality Engineer
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Sr. Quality Engineer
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Supplier Quality Engineer
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Sr. Quality Engineer
2 weeks ago
Merrimack Manufacturing Manchester, United StatesMerrimack 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 ma ...
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Sr. Quality Engineer
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Sanmina-SCI Manchester, United StatesSanmina Corporation (Nasdaq: SANM) is a leading integrated manufacturing solutions provider serving the fastest-growing segments of the global Electronics Manufacturing Services (EMS) market. Recognized as a technology leader, Sanmina Corporation provides end-to-end manufacturing ...
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Supplier Quality Engineer
1 hour ago
DEKA Research & Development Manchester, United StatesThe Supplier Quality Engineer will develop, maintain and support supplier quality assurance efforts to ensure that products and services meet specification requirements for components and assemblies. This role will communicate with suppliers to provide technical input and guidanc ...
Quality Engineer - Manchester, United States - Merrimack Manufacturing
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 Quality Engineer to 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.How you will make an impact:
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 processesDrive 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 devicesUse 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 issuesFacilitate the development, implementation, and approval of Device Master Records and Device History Records.
Review existing procedures and for continuous improvement and improved workflowLead 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 toolsProvide 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).
To be successful in this role, you will need the following skills and experience:Bachelor's degree or equivalent experience in Industrial, Mechanical or related engineering / life sciences related discipline.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.
