Post Market Surveillance - Quality Engineer

IPG Photonics Corporation; Marlborough (MA); On-site; USD 93,000 - 123,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) plan

Employee Stock Purchase Plan (ESPP)

Tuition Reimbursement

Employee Assistance Program (EAP)

Job summary

RadNet, Inc. is seeking a Post Market Surveillance Quality Engineer in Marlborough, MA to monitor IPG Medical devices post-market, drive CAPA, and collaborate with cross-functional teams to ensure patient safety and regulatory compliance.

The role involves leading investigations, trend analysis, risk updates (ISO 14971), and continuous improvement of surveillance processes in a regulated environment.

Qualifications

• Bachelor’s degree in engineering or related field required.
• 3–5 years of post-market surveillance experience in medical devices.
• Strong knowledge of medical device regulations and post‑market requirements.
• Detail oriented with ability to manage complex documentation in regulated environments.
• Strong analytical, communication and cross‑functional collaboration skills.
• Excellent technical writing, communication and cross‑functional collaboration skills.

Responsibilities

• Lead investigations of customer complaints, product failures and adverse events to determine root cause.
• Perform trend analysis using complaint and service data to identify quality issues.
• Apply statistics and quality engineering tools to evaluate product performance.
• Monitor device post-market performance to ensure regulatory compliance and safety.
• Collaborate with customers to gather accurate complaint information for failure analysis.
• Support risk management activities, including ISO 14971 updates based on post‑market data.
• Develop and improve post‑market surveillance procedures and processes for compliance.
• Maintain audit-ready records of surveillance activities and findings.
• Communicate with regulatory agencies and respond to inquiries.

Skills

Analytical skills

Cross-functional collaboration

Technical writing

Attention to detail

Regulatory knowledge

Communication

Education

Bachelor’s degree in engineering or related field

Tools

Medical device complaint handling systems

Job description

Post Market Surveillance - Quality Engineer

#26-492

Marlborough, Massachusetts, United States

Job Description

Job Summary

The Post Market Surveillance Quality Engineer is responsible for monitoring the performance, safety, and quality of IPG Medical devices throughout thepost-market lifecycleto ensure compliancewith global regulatoryrequirements and internalquality standards. Thisrole leads or facilitates complaintinvestigations, failureanalysis, adverse eventevaluations, and post-market trending activitieswhile collaborating withcross-functional teamsto identify productand process improvements. This role works directly with customers to gather accurate complaint information and supports failure analysis, adverse event investigations, and regulatory reporting. The engineer appliesquality engineering principles, risk management, andstatistical analysis todrive corrective andpreventive actions (CAPA), and enhance productreliability, patient safety, and continuous improvement.

Key Responsibilities

• Lead technical investigationsof customer complaints, product failures, andadverse events todetermine root cause.
• Perform trend analysisusing complaint and service datato identify emergingquality issues.
• Apply statistical methodsand quality engineeringtools to evaluateproduct performance andsupport decision-making.
• Monitor and evaluate the performance of medical devices in post-market settings to ensure compliance with applicable regulatory requirements and to maintain high levels of safety and quality.
• Work directly with customers to obtain complete and accurate complaint information and to support failure analysis activities.
• Conduct thorough and timely investigations of adverse events and complaints related to medical devices.
• Support risk managementactivities, including updatesto risk assessments(ISO14971) based onpost-market surveillancedata.
• Collaborate with cross-functional teams to gather and analyze data, identify trends, and support the implementation of corrective and preventive actions (CAPA).
• Develop, maintain, and continuously improve post-market surveillance procedures and processes to ensure compliance with regulatory standards.
• Maintain accurate, detailed, and audit-ready records of post-market surveillance activities, analyses, and findings.
• Communicate with regulatory agencies and respond to inquiries or requests related to post-market surveillance activities.
• Participate in internal and external audits and inspections to demonstrate compliance with regulatory requirements.
• Stay current on industry regulations, standards, and best practices related to post-market surveillance and communicate relevant updates to internal teams.
• Provide guidance and support to internal stakeholders on post-market surveillance requirements, processes, and regulatory expectations.
• Develop metrics, dashboards, andquality reports formanagement review.
• Identify opportunities for improvement and drive continuous improvement initiatives to enhance the safety, quality, and performance of IPG Medical devices.
• Act as a subject matter expert on post-market surveillance regulatory compliance for IPG Medical products.
• Promote a culture of patient safety, quality, and continuous improvement across the organization.

Requirements

Qualifications

• Bachelor’s degree in engineering or related field required
• At least 3- 5 years of experience in post-market surveillance within the medical device industry
• Strong knowledge of medical device regulations and post-market surveillance requirements
• Demonstrated attention to detail and ability to manage complex documentation in a regulated environment
• Strong analytical, communication, and cross-functional collaboration skills

Excellent technical writing, communication, andcross-functional collaborationskills

Experience with medicaldevice complaint handlingsystems (preferred)

Location(s)

225 Cedar Hill Street, Marlborough , Massachusetts 01752 , United States

Employment Type

Exempt

Wage Information

MA: $93,039 - $123,277

US Benefits Information

Pay Range:

The pay range on this posting applies to the role in the primary location specified. If the candidate would ultimately work outside of the primary location posted, the applicable range could differ. Actual starting pay is determined by a number of factors including relevant skills, qualifications, and experience.

Other Compensation: Employees in this role are eligible for additional rewards which could include:

• Annual Discretionary Bonus or Sales Bonus as Applicable

Benefits Provided: All Regular* US employees receive:

• Paid vacation time accrued based on years of service

*Prorated for reduced hour schedules

Additional Benefits Offered: IPG also offers access to:

• Medical, dental, and vision insurance plans with options for HSA/FSA
• Dependent Care FSA
• Paid Basic Life and AD&D Insurance
• Short-term and Long-term Disabilityinsurance
• 401(k) plan with Company matching
• Employee Stock Purchase Plan (ESPP)
• Tuition Reimbursement Program
• Employee Assistance Program (EAP)
• Adoption Assistance
• Pet Insurance
• Bright Horizons Backup Care
• Bright Horizons College Coach

*Benefits eligibility may differ by program for reduced hour schedules

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