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Sr Quality Engineer

Compliance & Regulatory Manufacturing & Distribution Akron, Ohio, US
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Performance Health is seeking a Sr. Quality Engineer to join our team in Akron. This position leads Quality Engineering related activities for internal and external drug and cosmetic manufacturers. Assures quality systems at internal and external manufacturing locations meet applicable US and international regulatory requirements.

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 execute drug stability program including protocol and study design, and report generation
• Perform Annual Product Reviews (APRs) 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 current FDA and ISO13485 requirement
• Participate in the design and launch of new products to ensure expectations for quality, performance, regulatory compliance, and delivery are understood and achievable
• Author and oversee validation plans to include user requirements, functional requirements, 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
• Investigate and identify industry trends in validation and expectations of regulatory agencies to ensure continued compliance to current drug stability program requirements
• Participate as subject matter exert during customer and external regulatory body audits and inspections
• Oversee internal & external audit program related to drug and cosmetic products manufacturing
• Identify and drive significant product and process Quality improvements via establishing effective cross functional relationships and use of proven data analysis tools/methodologies such as 6 Sigma, Lean, DOE, FMEA, and Gage R&R
• Proactively monitor product and process performance through application of process controls and testing to reduce variability
• Drive timely investigation of customer complaints in identifying potential cause(s) and determining if additional investigation and Corrective Action is required via the CAPA process
• Manage quality engineering team members
• Perform other duties as assigned

Job Qualifications
• Bachelors of Science degree in Engineering or other related technical field
• 5 years of experience within a medical drug/device regulated industry (e.g. FDA, ISO)
• Strong knowledge and application of validation principles and industry practices
• Demonstrated understanding of data-driven electronic quality 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
• Ability to travel 10% of the time, including overnight travel

Performance Health is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disab

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  • Manufacturing & Distribution, Akron, Ohio, United StatesRemove