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
--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