Quality Engineer - ISO 13485 Mfg - Sturbridge, MA
Michael Page International
- Sturbridge, Massachusetts
- 2 days ago
- $70,000–$95,000 Per Year
- Full-time
Highlights
The company is a well-established medical device manufacturer that provides a highly regulated, quality-driven environment with opportunities to make a direct impact on products and manufacturing processes. Bachelor's degree in Engineering or a related field, or 2-5 years of Quality Engineering experience in a regulated industry.
Numbers & Facts
| Location | Sturbridge, Massachusetts |
| Job Type | Full-time |
| Industry | Staffing/Employment Agencies |
| Salary | $70,000–$95,000 Per Year |
| Company Size | 10,000 employees or more |
| Website | https://www.michaelpage.ca/ |
Description
Quality Engineer
Own high-impact quality initiatives in a regulated MedTech environment.
$70K-$95K salary + full benefits starting day one.
About Our Client
The company is a well-established medical device manufacturer that provides a highly regulated, quality-driven environment with opportunities to make a direct impact on products and manufacturing processes. Employees benefit from a collaborative culture, professional growth opportunities, competitive compensation, and comprehensive benefits.
Job Description
Support QMS, FDA, ISO, and other regulatory requirements across manufacturing operations.
Support regulatory inspections, audits, investigations, and quality inquiries.
Monitor production and ensure compliance with DMRs, procedures, and quality requirements.
Lead product and process improvement initiatives using quality engineering methodologies.
Review BOMs, drawings, specifications, FMEAs, Control Plans, and related changes.
Lead risk analysis, test method validations, protocols, and technical reports.
Coordinate process validations, capability studies, and statistical quality activities.
Develop and implement incoming, in-process, and final inspection procedures.
Manage nonconforming materials, corrective actions, and complaint investigations.
Lead plant CAPA activities, including data analysis, trending, and root-cause investigations.
Support product transfers and new product introductions.
Partner with suppliers, engineers, manufacturing, and customers to resolve quality issues.
Develop Quality Plans covering inspection, testing, and gauge requirements.
Provide work direction to Quality Inspectors and Technicians as needed.
The Successful Applicant
Bachelor's degree in Engineering or a related field, or 2-5 years of Quality Engineering experience in a regulated industry.
2-5 years of experience in medical device or regulated manufacturing.
Working knowledge of ISO 13485, FDA regulations, MDSAP, ISO 14971, and QSR.
Strong understanding of quality engineering tools, statistical methods, and problem-solving techniques.
Experience with CAPA, risk management, FMEA, Control Plans, process validation, and quality systems.
Strong communication and cross-functional collaboration skills.
Proficiency with Microsoft Office and Minitab.
Ability to manage multiple priorities while maintaining accuracy and accountability.
Willingness to travel less than 10%.
What's on Offer
Competitive $70K-$95K salary range
Medical, dental & vision coverage from day one
401(k) and generous PTO plus 10 paid holidays
Strong opportunities for career growth and advancement
Hands-on ownership of quality, validation, CAPA, and process improvement
About Company
Michael Page is one of the world's leading professional recruitment consultancies, specializing in the placement of candidates in permanent, contract, temporary and interim positions with clients around the world.
Our business was established in Canada in 2005 when we opened our Toronto office. Our role is to work with employers and job seekers to facilitate a successful match. This can range from advising a global company on a candidate sourcing strategy to helping a job seeker find their dream job.
In Canada, we focus on recruiting for the following areas:
Banking and financial services
Digital and e-commerce
Engineering and manufacturing
Finance and accounting
Human resources
Information technology
Marketing
Oil and gas
Procurement and supply chain
Property and construction
Sales
An Established Brand
The Group has established a leading presence in many of the key markets for professional recruitment around the world and has positioned itself in certain other markets, which offer the opportunity for future growth. Within its current largest markets, Michael Page has also built a regional presence, including in the UK, France and Australia. Consequently, the Michael Page brand is among the most widely recognized brands in the professional recruitment industry.
A Market Leader
The role of a recruitment consultancy is to act as an intermediary, identifying and sourcing suitably qualified candidates on behalf of its clients. Candidates are recruited either for permanent or contract positions (typically for a fixed term) or on a temporary basis. Within the overall recruitment industry, the market for professional recruitment services is a specialist sector which has developed more recently. Michael Page is widely recognized as leading the development of this market around the world.
Learn the benefits of working with Michael Page yourself. Submit your resume or contact a Michael Page recruitment consultant today.