Quality Engineer
Confidential - Medical Device Company - Minneapolis, MN

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Immediate need for a _QUALITY ENGINEER._ with at least 5 years experience in medical device manufacturing. Must have experience working with FDA and ISO13485 QMS. .

Compensation includes salary, bonus, and possible equity.

--Responsibility for the implementation and maintenance of the QMS, including compliance to ISO 13485 and FDA registration requirements

--Management of corrective action processes, both internally and externally

--Performance of internal and external quality audits

--Providing on-going regulatory support for the company’s products and manufacturing partners; insuring compliance to all relevant regulations

--Reviewing and approving Engineering Change Orders, deviations, corrective actions, product and/or process change requests

--Reviewing and approving pre-launch and post launch product submission activities to ensure compliance with internal company requirements and external regulatory requirements

--Providing Quality Assurance input and guidance for supply chain, manufacturing, and R&D activities

--Working with external suppliers in creating and executing Design Verification test plans

--Supporting Product Development activities, including participation in design reviews, supplier change requests, product testing, etc.

--Managing all aspects of customer complaints, returns, field events, and MDR requirements

--Performing other duties as requested

--Relevant college degree. Engineering degree a plus.

--Minimum 5 years’ experience at medical device manufacturer

--Experience working with FDA and ISO13485 Quality systems

--Experience in auditing

--Team player

--Ability to work independently in a virtual environment

--Strong organization and time management skills

--Ability to effective communicate with all levels, internal and external to the organization

--Working knowledge of statistics

--Experience authoring and executing test process validation protocols, design verification tests

--Experience in 510k submissions

--ASQ certified auditor

Overview of Duties
--Complete materials database, including all raw materials used or coming in contact with our products: MSDS, datasheets, relevant biocompatibility test data, relevant leachability/extractability test data, direct or indirect contact, DEHP/latex free claims

--Qualify all Tier II suppliers, including site audits of QMS and gap analysis. Propose mitigation strategies commensurate with gap and associated risks.

--Implement QMS, identify gaps, recommend appropriate actions

--Evaluate document control system, make system recommendation if/as necessary; implement system, including control of all DHF documents, quality records, etc.

--Implement control plans throughout manufacturing processes for suppliers and internal incoming/receiving