Senior Medical Device Quality Engineer & SME Lead

Laborie Medical Technologies Corp; Portsmouth (NH); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Paid time off and volunteer time

Medical, Dental, Vision and FSA

Health Savings Account with Company F

401k Retirement Plan with CompanyMatch

Parental Leave and Adoption Services

Health and Wellness Programs andEvents

Job summary

Laborie is seeking a Senior Quality Engineer to serve as SME and mentor within the Quality Engineering function. You will drive validation strategies, lead investigations, and support design transfers for new or modified medical devices.

The role requires strong leadership, risk management, and regulatory experience with CFR 820 and ISO requirements. Join a mission-driven team focused on patient safety and product quality in the United States.

Qualifications

• Minimum 8 years of experience in technical medical device quality and compliance roles and a bachelor’s degree in an engineering or related scientific field.
• Minimum 6 years’ experience with a master’s degree in an engineering or related scientific field.
• Must possess the ability to write clear, concise and effective reports and procedures, learn quickly with guidance and training and work with minimal direct supervision.
• Computer literacy with experience in spreadsheet, database and word-processing applications.
• Processing and product evaluation experience.
• Knowledgeable of Quality System Regulation (CFR 820) and ISO requirements.
• Must be capable of establishing and maintaining an effective working relationship with manufacturing and technical personnel at all levels.
• Strong project management and organizational skills
• Proven track record of leadership
• Excellent communication and problem-solving skills
• Strong conflict resolution skills
• Proficient in quality tools
• Experience with Risk Management (ISO 14971 preferred).
• Experience with quality audits (lead auditor certification preferred).
• ASQ certification is preferred.
• Lean Six Sigma training preferred

Responsibilities

• Provide leadership and Subject Matter Expertise (SME) to Quality Engineering function and mentor less experienced Quality personnel.
• Develop strategies for validation of manufacturing processes, test methods, and quality processes.
• Lead Nonconforming product investigation, disposition, and approval with sound root cause analysis techniques that are well documented.
• Lead and support design/development activities for new or modified products and processes, including design transfer.
• Manage regulatory and quality projects with external agencies and test labs to ensure that the appropriate certification and testing is performed.
• Represent quality in the review and approval of proposed change orders, and deviations to determine the effect of the proposed changes on materials, products and processes.
• Develop, plan, and perform product, process monitoring & measurement activities.
• Investigate proposed process/product changes to ensure continued safety and quality.
• Perform investigations related to complaints and/or service.
• Maintain a thorough knowledge of current QSR and ISO requirements as they apply to the medical device industry.
• Develop and institute statistical techniques and trending to identify potential corrective or preventive actions.
• Initiate, plan, and perform corrective and preventative actions. Ensure timely resolution of corrective actions and preventive actions.
• Collaborate with design team personnel in the development of new products, utilizing engineering skills.
• Represent quality in the review and approval of proposed change orders, and deviations to determine the effect of the proposed changes on materials, products and processes.
• Recommend and implement process and product changes/improvements.
• Assist in the design/development activities for new or modified products and processes, including design transfer.
• Validate manufacturing processes, test methods, and quality processes as requested.
• Manage regulatory and quality projects with external agencies and test labs to ensure that the appropriate certification and testing is performed.
• Perform and document risk analysis and make decisions based on risk management principles.
• Maintain Risk Management File for assigned Laborie products.

Skills

Leadership

Project management

Quality systems

Risk management

Regulatory compliance

Excellent communication

Education

Bachelor’s degree in engineering or related scientific field

Master’s degree in engineering or related scientific field

Tools

Quality tools

Job description

Laborie is seeking a Senior Quality Engineer to serve as SME and mentor within the Quality Engineering function. You will drive validation strategies, lead investigations, and support design transfers for new or modified medical devices.

The role requires strong leadership, risk management, and regulatory experience with CFR 820 and ISO requirements. Join a mission-driven team focused on patient safety and product quality in the United States.