Manufacturing Quality Engineer

Performance Health; Akron (OH); On-site; USD 70,000 - 80,000; Full time

Job summary

A leading company in the healthcare sector is seeking a Manufacturing Quality Engineer in Akron, Ohio. The successful candidate will coordinate quality tasks, lead audits, and drive product quality improvements while ensuring compliance with regulatory standards. This full-time role offers a competitive salary and comprehensive benefits.

Benefits

Healthcare

Insurance benefits

Retirement programs

Paid time off

Family and parenting leaves

Wellness programs

Discount purchase programs

Qualifications

• 1-4 years of experience in a quality systems department within a regulated industry.
• Knowledge of FDA regulations and ISO standards preferred.
• Experience leading cross-functional projects.

Responsibilities

• Lead nonconformance & CAPA activities to ensure compliance.
• Drive investigations of customer complaints and corrective actions.
• Support document change controls and conduct risk-based assessments.

Skills

Data-driven analysis

Problem-solving

Quality improvement

Root cause analysis

Education

Bachelor’s degree in Engineering

Tools

Minitab

Excel pivot tables

Job description

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. This position also involves partnering closely with operations to support and guide the effective execution of quality processes and drive product quality improvements.

Essential Job Duties & Responsibilities

1. Lead nonconformance & CAPA activities to ensure compliance, timeliness, and effectiveness.
2. Drive investigations of customer complaints, identify potential causes, and determine if further investigation and corrective actions are required via the CAPA process.
3. Identify and promote product quality improvements through proactive data analysis and collaboration with Operations.
4. Guide site in the effective use of root cause investigation tools such as 5Y's, 8D, Cause/Effect, DOE, FMEA, statistical controls, and Gage R&R analyses.
5. Support document change controls and conduct risk-based assessments of changes.
6. Lead site Quality training activities and coordinate with subject matter experts.
7. Lead internal and supplier audits; support external audits.
8. Compile post-market surveillance data and generate reports and technical documents.
9. Support continuous improvement and kaizen activities.
10. Ensure appropriate test criteria, inspection points, measurement equipment, and methodology are established and documented.
11. Provide guidance on process verification and validation techniques such as IQ, OQ, PQ.
12. Assist with external regulatory audits & inspections, participating as subject matter expert as applicable.
13. Participate in the design and launch of new products to ensure quality, performance, and regulatory compliance.
14. Participate in supplier selection and maintenance, managing supplier audits and resolving defects.
15. Perform other duties as assigned.

Job Qualifications

• Bachelor’s degree in Engineering.
• 1-4 years of experience in a quality systems department within a regulated industry governed by regulations such as FDA 21 CFR Parts 803, 806, & 820, ISO 14971, and ISO 13485.
• Proven experience with data-driven electronic quality data analysis tools such as Minitab & Excel pivot tables, and problem-solving methodologies like Six Sigma and SPC.
• Knowledge of ISO/EU MDR, and FDA requirements for Medical Device or OTC Drug Products is strongly preferred.
• Knowledge of process validation reports and test protocols for software and equipment (IQ, OQ, PQ), including statistical controls.
• Experience leading cross-functional projects.

Benefits

Our benefits include healthcare, insurance benefits, retirement programs, paid time off, family and parenting leaves, wellness programs, and discount purchase programs.

This is a full-time position with a base salary range of $70,000 - $80,000, plus bonus potential and benefits.