Quality Manager

Akkodis; Toronto; On-site; USD 120,000 - 130,000; Full time

Job summary

A leading technology and services firm is seeking a Quality Manager to oversee the Quality Management System for a medical device manufacturer. The ideal candidate will have substantial experience with FDA and ISO regulations and proven leadership skills. Key responsibilities include managing audits, analyzing data for quality strategies, and leading a quality team. The role is based in the Dayton, OH area and offers competitive benefits and a commitment to innovation.

Benefits

Medical, dental, and vision insurance

401K plan

Commuter benefits

Qualifications

• 6+ years of relevant experience in quality management, preferably in a regulated industry.
• Strong verbal and written communication skills.
• Proficient in interpreting and analyzing scientific journals and regulatory guidelines.
• Comfortable working in both office and manufacturing environments.

Responsibilities

• Lead implementation and improvement of the Quality Management System.
• Direct efforts related to regulatory audits and quality certifications.
• Analyze operational data to inform quality strategies.
• Manage and develop a cross-functional quality team.
• Collaborate with R&D and manufacturing teams to support design controls.

Skills

Strategic quality management

FDA and ISO 13485 knowledge

Leadership skills

Analytical skills

Problem-solving

Education

Bachelor’s degree in a related field

Master’s degree preferred

Job description

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Base pay range

120,000.00 / yr - $130,000.00 / yr

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Akkodis is currently seeking a Quality Manager for a medical device manufacturer in the Dayton, OH metropolitan area. The ideal candidate for this position is a detail-oriented and strategic quality professional with deep knowledge of FDA and ISO 13485 regulations, hands-on experience managing quality systems in a regulated environment, and strong leadership skills in guiding cross-functional teams. This organization offers a dynamic and mission-driven work environment, competitive benefits, and a strong commitment to innovation, compliance, and continuous improvement in the development of life-enhancing medical technologies.

Salary Range : $120,000-$130,000

Key Responsibilities :

• Lead the implementation, maintenance, and improvement of the company’s Quality Management System (QMS) in accordance with FDA 21 CFR Part 820, ISO 13485, and other applicable global regulatory requirements.
• Direct internal efforts related to regulatory audits, inspections, and quality system certifications.
• Analyze operational data related to manufacturing, product design, field performance, and market trends to inform quality strategies and risk mitigation efforts.
• Oversee document control processes, ensuring timely review and approval of controlled documents, records, and design history files.
• Manage and develop a cross-functional quality team including QA engineers, inspectors, and internal auditors.
• Evaluate and optimize quality control procedures for in-process and final inspections of medical devices, ensuring compliance with validated processes and product specifications.
• Collaborate with R&D, manufacturing, and regulatory teams to support design controls, verification / validation, and design transfer activities.
• Drive continuous improvement initiatives using tools such as CAPA, root cause analysis, and risk management.
• Review quality metrics and quality-related financial data to support budget planning and operational effectiveness.
• Lead cross-functional meetings to define and review quality objectives, establish interdepartmental responsibilities, and ensure alignment with business goals.
• Work closely with external suppliers to evaluate material compliance, capacity, and adherence to medical device quality standards (e.g., supplier qualification and audits).
• Partner with engineering teams to resolve quality issues across the product lifecycle—from design through post-market surveillance.
• Perform other duties as required to support regulatory readiness, product safety, and organizational quality culture.

Qualifications

Bachelor’s degree in a related field required; Master’s degree preferred, or equivalent combination of education and experience

6+ years of relevant experience in quality management, preferably in a regulated industry

Strong verbal and written communication skills, including the ability to interpret technical documents and effectively present to senior leadership and external stakeholders

Proficient in interpreting and analyzing scientific journals, legal documents, financial reports, and regulatory guidelines

Advanced mathematical skills, including knowledge of statistical analysis, sampling theory, and variance analysis

Strong problem-solving and analytical skills, with the ability to work with both abstract concepts and technical data

Comfortable working in both office and manufacturing environments; must adhere to safety protocols on the production floor

Physically capable of lifting up to 50 lbs and performing tasks requiring standing, walking, and manual dexterity

Ability to travel occasionally, both domestically and internationally, to support business operations

Full-time availability, Monday through Friday, with flexibility to work additional hours as needed

This position is open to exceptional relocation candidates.

If you are interested in this onsite position in the Dayton, OH metropolitan area, then please click APPLY NOW. For other opportunities available at Akkodis go to www.akkodis.com. If you have questions about the position, please contact Ryan Miller at [e-mail].

Equal Opportunity Employer / Veterans / Disabled

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer : These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https : / / www.modis.com / en-us / candidate-privacy /

The Company will consider qualified applicants with arrest and conviction records.

Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Full-time

Job function

Job function

Quality Assurance

Industries

Manufacturing

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