IPG Photonics
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Job Summary
The Post Market Surveillance Specialist is responsible for monitoring the performance and safety of IPG Medical devices in postmarket settings to ensure compliance with global regulatory requirements and to maintain high standards of quality and patient safety. This role works directly with customers to gather accurate complaint information and supports failure analysis, adverse event investigations, and regulatory reporting. The specialist collaborates crossfunctionally to identify trends, drive corrective and preventive actions, and promote continuous improvement throughout the product lifecycle.
Key Responsibilities
- Monitor and evaluate the performance of medical devices in postmarket 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.
- Collaborate with crossfunctional teams to gather and analyze data, identify trends, and support the implementation of corrective and preventive actions (CAPA).
- Develop, maintain, and continuously improve postmarket surveillance procedures and processes to ensure compliance with regulatory standards.
- Maintain accurate, detailed, and auditready records of postmarket surveillance activities, analyses, and findings.
- Communicate with regulatory agencies and respond to inquiries or requests related to postmarket 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 postmarket surveillance and communicate relevant updates to internal teams.
- Provide guidance and support to internal stakeholders on postmarket surveillance requirements, processes, and regulatory expectations.
- 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 postmarket surveillance and regulatory compliance for IPG Medical products.
Promote a culture of patient safety, quality, and continuous improvement across the organization.
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Qualifications
- Bachelor’s degree or equivalent relevant work experience required.
- At least 3- 5 years of experience in postmarket surveillance within the medical device industry.
- Strong knowledge of medical device regulations and postmarket surveillance requirements.
- Demonstrated attention to detail and ability to manage complex documentation in a regulated environment.
- Strong analytical, communication, and crossfunctional collaboration skills.
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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
- Paid sick time
- 12 (twelve) Paid Holidays Each Calendar Year
- 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
- Parental Bonding Leave
- Bright Horizons Backup Care
- Bright Horizons College Coach
*Prorated for reduced hour schedules
Additional Benefits Offered: IPG also offers access to:
*Benefits eligibility may differ by program for reduced hour schedules
Deadline and How to Apply
This job posting will remain active until a candidate is identified and/or the Company rescinds the job posting.
For full consideration, please click on the link to apply.
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“Equal Opportunity Employer / Affirmative Action M/F D/V
IPG Photonics Corporation is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. All employment decisions and personnel actions at IPG Photonics are administered without regard to race, color, religion, creed, national origin, ancestry, sex, age, qualified mental or physical disability, gender identity, sexual orientation, genetic carrier status, any veteran status, any military service, any Application for any military service, or any other category or class protected by applicable federal, state or local laws. IPG Photonics Corporation provides reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974 and Title I of the Americans with Disabilities Act of 1990. Applicants who need accommodation in the job application process should contact (508) 506-2527 or email [email protected] opens an email client applicationto request assistance. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to.
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