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Senior Quality Engineer Medical Device Jobs in Wauseon, OH

TriMas Corporation

Senior Quality Engineer

Clinton, MI · On-site

$87.50K - $118.60K/yr

Senior Quality Engineer Company: Omega Plastics Inc Primary Location: 24401 Capital Blvd, Clinton ... Benefits Benefit offerings include Medical Insurance and Prescription Drugs, Dental Insurance ...

BSI Group

Medical Device QMS Auditor

Toledo, OH · Remote

$98.10K - $123.86K/yr

Analyze quality systems and assess ISO 13485, CE Marking and MDSAP schemes. * Prepare assessment ... Associate's degree or higher in Engineering, Science or related degree required * Minimum of 4 ...

Pwc

Quality Engineer - Senior Manager

Toledo, OH · On-site

$124K - $280K/yr

... quality engineering efforts, confirming the utmost standards of software quality. As a Senior ... PwC offers a wide range of benefits, including medical, dental, vision, 401k, holiday pay, vacation ...

M.C. Dean, Inc

Quality Engineer 2

Bowling Green, OH · On-site

$67.60K - $87.30K/yr

The Quality Control 3 Engineer is responsible for overseeing field inspections to ensure work is in ... Medical, dental, vision, life, and disability insurance * Paid time off * Tuition reimbursement ...

Hercules Materials Holdings LLC

SR QC Tech

Toledo, OH · On-site

In this role, the QC Tech works hands-on with our management team and the customers that we are ... Act as a company liaison between our production team, sales, site engineers, inspectors and ...

TriMas Corporation

Project Engineer

Clinton, MI · On-site

Adherence to ISO procedures. * Assist in quality CAPAs. * Utilize continuous improvement, lean and ... Experience in the medical device industry or ISO environment is desirable * Experience in the ...

Danaher

Software Engineer Internships

Toledo, OH

Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2025 or later with a Bachelor's degree in Computer Science, Software Engineering ...

TriMas Corporation

Process Engineer

Clinton, MI · On-site

Collaborate with tooling, quality, and program management teams to ensure successful project ... the medical device, diagnostic, pharmaceutical and surgical markets. The company serves key ...

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Senior Quality Engineer Medical Device information

See Wauseon, OH salary details

$56.8K

$98.8K

$137.5K

How much do senior quality engineer medical device jobs pay per year?

As of May 28, 2026, the average yearly pay for senior quality engineer medical device in Wauseon, OH is $98,823.00, according to ZipRecruiter salary data. Most workers in this role earn between $83,100.00 and $112,600.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Senior Quality Engineer in Medical Devices, and why are they important?

To excel as a Senior Quality Engineer in Medical Devices, you need a solid background in engineering, quality assurance, and regulatory compliance, typically with a relevant degree and experience in the medical device industry. Familiarity with ISO 13485, FDA 21 CFR Part 820, risk management tools (such as FMEA), and quality management systems is crucial, and certifications like CQE or Six Sigma are often preferred. Strong problem-solving, attention to detail, and effective communication skills distinguish top performers in this role. These competencies ensure product safety, regulatory compliance, and the continuous improvement of processes critical to patient outcomes and company success.

How does a Senior Quality Engineer in the medical device industry typically collaborate with cross-functional teams during product development?

As a Senior Quality Engineer in the medical device sector, you will work closely with cross-functional teams including R&D, manufacturing, regulatory affairs, and supply chain. Your role involves ensuring quality standards are integrated throughout the product lifecycle, from design reviews and risk assessments to process validation and compliance documentation. Regular meetings, joint problem-solving sessions, and clear communication are vital to resolve issues efficiently and maintain regulatory compliance. This collaborative environment helps to ensure both product safety and timely market release.

What are Senior Quality Engineers in the medical device industry?

Senior Quality Engineers in the medical device industry are professionals responsible for ensuring that medical devices meet regulatory standards and quality requirements throughout their lifecycle. They lead quality assurance activities, develop and implement testing protocols, coordinate with design and manufacturing teams, and help ensure compliance with relevant regulations such as FDA and ISO standards. Their expertise ensures that products are safe, effective, and reliable for patient use. They also mentor junior engineers and may play a key role in audits and process improvements.

What is the difference between Senior Quality Engineer Medical Device vs Quality Engineer Medical Device?

AspectSenior Quality Engineer Medical DeviceQuality Engineer Medical Device
ResponsibilitiesLead quality initiatives, oversee audits, mentor team membersAssist in quality processes, support audits, perform inspections
Experience & CertificationsTypically 5+ years, often ISO 13485, FDA regulationsEntry to mid-level, basic knowledge of industry standards
Work EnvironmentLeadership roles, cross-functional teams, strategic planningOperational tasks, documentation, compliance support
Usage & IndustryCommonly used in manufacturing, R&D, and quality departmentsUsed across similar settings, often as a stepping stone role

The main difference between a Senior Quality Engineer Medical Device and a Quality Engineer Medical Device lies in experience, responsibilities, and leadership scope. Senior roles involve strategic oversight and mentorship, while standard Quality Engineers focus on supporting quality processes and compliance tasks.

What are popular job titles related to Senior Quality Engineer Medical Device jobs in Wauseon, OH? For Senior Quality Engineer Medical Device jobs in Wauseon, OH, the most frequently searched job titles are:
What job categories do people searching Senior Quality Engineer Medical Device jobs in Wauseon, OH look for? The top searched job categories for Senior Quality Engineer Medical Device jobs in Wauseon, OH are:
What cities near Wauseon, OH are hiring for Senior Quality Engineer Medical Device jobs? Cities near Wauseon, OH with the most Senior Quality Engineer Medical Device job openings:
Senior Quality Engineer Medical Device jobs near you
Senior Quality Engineer

Senior Quality Engineer

TriMas Corporation

Clinton, MI • On-site

$87.50K - $118.60K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 19 days ago

Job description

Senior Quality Engineer
Company: Omega Plastics Inc
Primary Location: 24401 Capital Blvd, Clinton Township, MI 48036 USA
Workplace Type: On-site
Employment Type: Salaried Full-Time
Function: Engineering
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
Main Duties & Responsibilities
OmegaPlastics, Inc. has an opening for a Senior Quality Engineer at 24401 CapitalBlvd., Clinton Twp., MI 48036. 40 hrs/wk. 9am - 5pm. M-F.
Responsibilities:
Spearhead Non-Conformances, CAPA,SCAR, and customer complaints activities which include root causeinvestigations, material disposition, risk analysis, and implementation ofCorrective Action Preventative Action Plan.
Develop, and review IQ/OQ/PQ ValidationProtocols, Summary Reports, Validation Master Plans for products, andmanufacturing processes per ISO 13485, and 21 CFR 820 regulations.
SupportQuality Management System development by creating Procedures and WorkInstructions in support of ISO13485 and 21CFR820 compliance.
Lead Softwarevalidation projects to include documentation creation - Test Plans, UserRequirement Specification (URS), protocols, Test Method Validation (TMV), andSummary Reports; generate Risk Management Documentation - Process Flow Diagram(PFD), pFMEA, and Control Plan (CP) per ISO14971 for process, product, andsecondary operations.
Review and approve documentation such as Quality Plans,Inspection Reports, Change Controls, and Non-conformances to release for validationand commercial activities.
Support New Product Introduction (NPI) and ProcessDevelopment processes which include feasibility, kickoff, and gate reviews.
Conduct Internal audit, collaborate with teams to resolve findings, generateneeded records and reports.
Qualifications
Requirements:
Bachelor's degree in Biomedical Engineering, or Aerospace Engineering, or Mechanical Engineering, or foreign degree equivalent, plus of 1 year of experience in Quality Engineer and/or QA/RA Specialist and/or quality assurance positions.
Experience must include: ISO-13485 standards and 21 CFR-820 regulatory compliance; ISO 14971 and risk management, such as pFMEA, Control Plans, and Process Flow Diagrams; Measurement System Analysis (MSA), Gage R&R, Process Capability Studies (Cp, Cpk), and use of tools like Minitab; Corrective and Preventive Action (CAPA) processes, utilizing tools such as 5 Whys, 8D, Fishbone, and DMAIC; and Quality Management Systems (QMS), including execution of internal audits, audit readiness support, and document control in compliance with cGMP and ISO standards.
Applicants should apply at: https://trimascorp.csod.com/ux/ats/careersite/16/home?c=trimascorp. Include Reference # 144218-6 w/resume.
Omega Plastics, Inc. is an equal opportunity/affirmative action employer.
Benefits
Benefit offerings include Medical Insurance and Prescription Drugs, Dental Insurance, Vision Insurance, Flexible Spending Accounts, Life Insurance, Short-Term Disability, Long-Term Disability Insurance (for eligible employees), Employee Assistance Plan (EAP), Paid Time Off (may include vacation and sick time), Retirement Program, and Other Voluntary Benefits.
Click here for more information: www.trimasbenefits.com
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About TriMas

Sourced by ZipRecruiter

Industry

Plastics packaging film and sheet (including laminated) manufacturing

Company size

5,001 - 10,000 Employees

Headquarters location

Bloomfield Hills, MI, US

Year founded

1988

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