Overview
Quality Engineer Jobs in Akron, Ohio, USA at Performance Health
Manufacturing Quality Engineer
Quality Assurance Manufacturing & Distribution Akron, Ohio, US
Performance Health is seeking a Manufacturing Quality Engineer to join our team in Akron, OH. In this role, you will be responsible for coordinating and administering quality tasks including leading internal and supplier audits, handling site complaints, nonconformance, CAPA & quality training activities, and supporting document change control & supplier qualification. You will work closely with operations to ensure compliant and effective quality processes and drive product quality improvements.
Essential
Job Duties
& Responsibilities
Lead nonconformance & CAPA activities for compliant and timely resolution.
Investigate customer complaints, identify causes, and determine if further investigation and corrective actions are needed via the CAPA process.
Drive product quality improvements through data analysis and collaboration with Operations.
Guide site in root cause analysis techniques such as 5Y’s, 8D, Cause/Effect, DOE, FMEA, statistical controls, and Gage R&R analyses.
Support document change controls and conduct risk assessments of changes.
Lead site quality training activities and coordinate with subject matter experts.
Conduct internal and supplier audits; support external audits.
Compile post-market surveillance data and generate reports and technical documents.
Participate in continuous improvement and Kaizen activities.
Ensure test criteria, inspection points, measurement equipment, and methodologies are well-established and documented.
Provide guidance on process verification and validation (IQ, OQ, PQ).
Assist with external regulatory audits and inspections, serving as subject matter expert.
Participate in new product design and launch to ensure quality and regulatory compliance.
Manage supplier selection and maintenance through audits and defect resolution.
Perform other duties as assigned.
Job Qualifications
Bachelor’s degree in Engineering.
1-4 years of experience in a regulated quality systems environment (FDA, ISO, EU MDR).
Experience with data analysis tools (Minitab, Excel pivot tables) and problem-solving methodologies (Six Sigma, SPK).
Knowledge of process validation reports, test protocols, and statistical controls.
Preferred:
Knowledge of FDA, ISO 13485, and EU MDR regulations for Medical Devices or OTC Drugs.
Benefits
Our benefits include healthcare, insurance, retirement programs, paid time off, family leave, wellness programs, and discount purchase programs. This is a full-time position with a salary range of $70,000 – $80,000, plus bonus potential and benefits.
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Title: Quality Engineer
Company: Performance Health
Location: Akron, Ohio, USA
Category: Quality Assurance – QA/QC (Quality Engineering, QA Specialist / Manager), Engineering (Quality Engineering, QA Specialist / Manager, Process Engineer)
