Quality Engineer265 Regulatory Manufacturing & Distribution Cedarburg, Wisconsin, US
Performance Health is seeking a Quality Engineer to join our manufacturing team in Cedarburg, WI. This position performs Quality Engineering related activities for internal and contract manufacturers. Assures quality systems at internal and external manufacturing locations meet applicable US and international regulatory requirements. Product mix may include drugs, medical devices, cosmetics and consumer products.
To perform this job successfully, an individual must be able to perform each essential job duties satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Essential Job Duties & Responsibilities
- Oversee and support private label supplier quality
- Perform Annual Product Reviews (APRs), if applicable, and Post Market Surveillance (PMS) reports in compliance with FDA and EU requirements
- Submit required drug and/or device technical data & documentation to applicable Regulatory agencies for items such as labeling and product listings
- Develop and maintain required Standard Operating Procedures (SOPs), Work Instructions (WIs) and guidelines for validation policies, standards, procedures, and templates including test cases to ensure internal and external manufacturing Quality Systems are in compliance with ISO13485, US, UK, EU and other applicable requirements.
- Participate in the design and launch of new products to ensure expectations for quality, performance, regulatory compliance, and delivery are understood and achievable
- Author validation plans; Oversee and provide direction for the development of: specifications for user requirements, functional requirements, and design requirements, trace matrices, validation summary reports and test protocols for installation, operation, and performance of both software and equipment (e.g. IQ’s, OQ’s, PQ’s)
- Arrange contract validation services as required. This includes contract review, coordination of approvals and interface with contract service to ensure resources meet validation project deliverables inclusive of schedule and budget
- Participate and oversee customer and external regulatory body audits and inspections
- Identify and drive significant product and process Quality improvements by establishing effective cross functional relationships and use of proven data analysis tools/methodologies such as 6 Sigma, Lean, DOE, FMEA, and Gage R&R
- Drive timely investigation of customer complaints and determining if additional investigation and Corrective Action is required via the CAPA process
- Perform other duties as assigned
- Bachelor’s Degree in Engineering or related technical field
- 2-5 years of experience as a Quality Engineer
- Knowledge and application of validation principles and industry practices
- Demonstrated understanding of data analysis tools such as Minitab & Excel pivot tables, and problem solving methodologies such as 6 Sigma, and SPC
- Strong knowledge and understanding of FDA 21 CFR Part 803, 806, & 820, ISO 14971 and ISO13485 regulatory/quality standards as pertaining to Design & Production controls
- Experience interacting with the FDA and other regulated bodies during inspections/audits, and in fulfilling requests for information
- Ability to travel up to 10% of the time; including
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