Michael Page
Quality Systems Engineer - Medical Devices - Tewksbury, MA
Michael Page - Tewksbury, Massachusetts, us, 01876
Work at Michael Page
Overview
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Overview
Growth Opportunities Available into Management
State of the art production and laboratory
About Our Client
My client is an innovative medical technology company focused on improving outcomes for patients with critical health conditions. They develop advanced systems that support the preservation and use of biological materials in clinical settings. With a mission-driven culture and a strong focus on engineering, the company offers a fast-paced, collaborative environment where teams work on cutting-edge solutions that have real-world impact.
Job Description
The Quality Systems Engineer, Medical Devices will:
Support and maintain compliance with the Quality Management System (QMS), including CAPA, NCMRs, Supplier Controls, Management and Risk Reviews. Coordinate and manage the CAPA program: administration, record keeping, quality input for investigations, reporting, and trend analysis. Assist CAPA owners with problem-solving techniques such as Root Cause Analysis, DOE, and FMEA. Manage the Internal Audit program: schedule audits, track findings, ensure timely corrective actions, and analyze audit metrics. Provide subject matter expertise and support during external audits and inspections. Develop, collect, and analyze quality metrics for monthly reviews and management meetings. Lead or participate in Risk Management and FMEA activities. Identify and implement Quality System improvements, including creating or revising documentation to close gaps. Escalate quality issues to leadership with clear data presentation to facilitate decision-making. Deliver training and support to employees on quality processes and procedures. Provide cross-functional quality assurance support across the organization. Support development and execution of quality plans, processes, and special projects as needed Onsite at our Tewksbury, MA location 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, Biomedical Science, or a related technical field preferred. 5-7 years of relevant medical device industry experience with responsibility for Product Quality and/or Quality Systems. Working knowledge of Quality System regulations and standards, including 21 CFR Part 820, ISO 13485, and EU MDR. Experience in developing, documenting, and implementing quality procedures and processes. Proven ability to manage multiple projects and adapt to changing priorities effectively. Results-driven mindset with a strong sense of urgency and accountability. Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, and Access. Experience in internal and external audits, preferably as a qualified internal auditor. Strong written and verbal communication skills for clear and effective information exchange. Independent judgment and decision-making capability in applying quality methods and evaluation. Solid problem-solving skills with the ability to identify and resolve issues proactively. Excellent interpersonal skills, able to collaborate across diverse cross-functional teams. Local to Tewksbury, MA What's on Offer
Competitive base salary with comprehensive benefits package Access to a world-class laboratory and modern production facilities Onsite perks including free parking, fitness center, cafeteria, and coffee shop Robust health, dental, vision, and life insurance coverage Short- and long-term disability insurance 401(k) retirement savings plan with employee contribution options Flexible spending accounts for healthcare and dependent care needs Generous paid time off, including vacation and holidays Employee Stock Purchase Plan (ESPP) Fast-paced, mission-driven environment working on life-saving medical technology Opportunity to collaborate with highly skilled, innovative colleagues in a growing company
Contact
Isabel Reynes
Quote job ref
JN-072025-6790223
My client is an innovative medical technology company focused on improving outcomes for patients with critical health conditions. They develop advanced systems that support the preservation and use of biological materials in clinical settings. With a mission-driven culture and a strong focus on engineering, the company offers a fast-paced, collaborative environment where teams work on cutting-edge solutions that have real-world impact.
Job Description
The Quality Systems Engineer, Medical Devices will:
Support and maintain compliance with the Quality Management System (QMS), including CAPA, NCMRs, Supplier Controls, Management and Risk Reviews. Coordinate and manage the CAPA program: administration, record keeping, quality input for investigations, reporting, and trend analysis. Assist CAPA owners with problem-solving techniques such as Root Cause Analysis, DOE, and FMEA. Manage the Internal Audit program: schedule audits, track findings, ensure timely corrective actions, and analyze audit metrics. Provide subject matter expertise and support during external audits and inspections. Develop, collect, and analyze quality metrics for monthly reviews and management meetings. Lead or participate in Risk Management and FMEA activities. Identify and implement Quality System improvements, including creating or revising documentation to close gaps. Escalate quality issues to leadership with clear data presentation to facilitate decision-making. Deliver training and support to employees on quality processes and procedures. Provide cross-functional quality assurance support across the organization. Support development and execution of quality plans, processes, and special projects as needed Onsite at our Tewksbury, MA location 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, Biomedical Science, or a related technical field preferred. 5-7 years of relevant medical device industry experience with responsibility for Product Quality and/or Quality Systems. Working knowledge of Quality System regulations and standards, including 21 CFR Part 820, ISO 13485, and EU MDR. Experience in developing, documenting, and implementing quality procedures and processes. Proven ability to manage multiple projects and adapt to changing priorities effectively. Results-driven mindset with a strong sense of urgency and accountability. Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, and Access. Experience in internal and external audits, preferably as a qualified internal auditor. Strong written and verbal communication skills for clear and effective information exchange. Independent judgment and decision-making capability in applying quality methods and evaluation. Solid problem-solving skills with the ability to identify and resolve issues proactively. Excellent interpersonal skills, able to collaborate across diverse cross-functional teams. Local to Tewksbury, MA What's on Offer
Competitive base salary with comprehensive benefits package Access to a world-class laboratory and modern production facilities Onsite perks including free parking, fitness center, cafeteria, and coffee shop Robust health, dental, vision, and life insurance coverage Short- and long-term disability insurance 401(k) retirement savings plan with employee contribution options Flexible spending accounts for healthcare and dependent care needs Generous paid time off, including vacation and holidays Employee Stock Purchase Plan (ESPP) Fast-paced, mission-driven environment working on life-saving medical technology Opportunity to collaborate with highly skilled, innovative colleagues in a growing company
Contact
Isabel Reynes
Quote job ref
JN-072025-6790223