Michael Page International logo

Quality Engineer - Medical Device - Shirley, MA

Michael Page International
  • Shirley, MA
  • $95,000–$105,000 Per Year
  • Full-time
  • Instant Apply
30+ days ago
Michael Page International

Job Description

Join A Growing Medical Manufacturing Leader Shaping Quality Excellence

Our client is a globally recognized manufacturing organization known for innovation, operational excellence, and a strong commitment to quality. As part of a larger international group, the company offers outstanding career development opportunities, collaborative teams, and an inclusive culture focused on employee growth and well being.

Job Description

Develop, implement, and maintain Quality Management System (QMS) processes, procedures, templates, and controlled documentation.

Support New Product Introduction (NPI) programs by ensuring all quality requirements and deliverables are completed efficiently and compliantly.

Partner with validation experts to oversee product and process verification and validation activities.

Lead investigations into quality events, product nonconformances, process deviations, and customer complaints.

Drive robust CAPA activities using structured root cause methodologies including 5 Whys, Fishbone Analysis, and FMEA.

Evaluate and support product, process, and design changes through comprehensive risk and impact assessments.

Collaborate with cross-functional teams to identify and implement process and product quality improvements.

Support validation protocol development, execution, and life cycle documentation maintenance.

Participate in internal audits and generate findings that support compliance and continuous improvement.

Deliver training and guidance on quality tools, systems, and best practices.

Champion a culture of quality, compliance, risk awareness, and continuous improvement throughout the organization.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

Bachelor's degree in Engineering or a related scientific discipline.

2-3+ years of Quality Engineering or Quality Assurance experience within a regulated environment.

Strong knowledge of ISO 13485 and/or ISO 9001 standards.

Experience supporting product and process validation activities.

Understanding of design control and product development lifecycles.

Internal auditing experience; Lead Auditor certification is a plus.

Proven success driving continuous improvement initiatives and Lean methodologies.

Strong root cause analysis and CAPA management experience.

Excellent communication, project management, and stakeholder engagement skills.

Ability to thrive in a fast-paced, evolving manufacturing environment.

What's On Offer

Industry-leading parental leave and family planning benefits.

Strong 401(k) program with employer contributions and matching.

Opportunity to work on innovative products in a highly regulated environment.

Exposure to cross-functional projects and new product development initiatives.

Inclusive culture with significant investment in employee growth, wellbeing, and career progression.

Numbers & Facts

LocationShirley, MA
Job TypeFull-time
IndustryStaffing/Employment Agencies
Salary$95,000–$105,000 Per Year
Company Size10,000 employees or more
Websitehttps://www.michaelpage.ca/

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.

Skills

  • Analysis Skillsunmatched
  • Auditingunmatched
  • Best Practicesunmatched
  • Communication Skillsunmatched
  • Continuous Improvementunmatched
  • Corrective and Preventative Action (CAPA) Systemsunmatched
  • Cross-Functionalunmatched
  • Document Managementunmatched
  • Documentationunmatched
  • Failure Mode and Effects Analysis (FMEA)unmatched
  • ISO (International Organization for Standardization)unmatched
  • ISO 9001unmatched
  • Internal Auditunmatched
  • Lean Manufacturingunmatched
  • Manufacturingunmatched
  • Medical Equipmentunmatched
  • Process Improvementunmatched
  • Process Validationunmatched
  • Product Designunmatched
  • Product Developmentunmatched
  • Product Lifecycleunmatched
  • Product Programsunmatched
  • Product Supportunmatched
  • Product Testingunmatched
  • Product/Service Launchunmatched
  • Project/Program Managementunmatched
  • Quality Engineeringunmatched
  • Quality Managementunmatched
  • Risk Analysisunmatched
  • Root Cause Analysisunmatched
  • Systems Maintenanceunmatched
  • Team Playerunmatched
  • Track Customer Issuesunmatched
  • Training/Teachingunmatched
  • Validation Planunmatched
  • Validation Testingunmatched

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