Ready to make a difference by utilizing your talents? Join a team driven by a mission to help patients, and a culture focused on developing medical device and diagnostic solutions.
Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease.
The Senior Complaints Specialist will establish a centralized, efficient, and robust complaints reporting process. They are responsible for driving activities associated with complaint handling and regulatory reporting submissions associated with complaints processing. They will maintain oversight of all activities associated with the complaints process to ensure accurate data and timeliness are maintained from initiation to closure. Partner with Sales, Marketing, Customer Care, Engineering, and other functional experts as needed to ensure a clear understanding and an investigation is completed. They will provide training to others in company highlighting the importance and benefit of a robust complaints process.
- Enhance the company wide complaints process to drive consistency across facilities and product lines.
- Process complaints and regulatory (MDR, Vigilance, other) reports to ensure that complaints are documented, reviewed, evaluated, investigated, and formally closed in a timely manner.
- Interface directly with sales team and customers to ensure thorough investigations
- Internal and external customers and regulatory agencies as required.
- Primary support for any external/internal audits as the subject matter expert on complaints/reporting process.
- Prepare and contribute to responses to regulatory inquiries as needed.
- Establish consistent quality metrics development and monitoring across product lines and facilities,
- Conduct regular product performance reviews around complaints/failure investigations.
- Drive continuous improvements for the complaints process for the company.
- Provide support to the overall Quality functions as needed, including field actions, corrective actions, and others.
- May be assigned other responsibilities of the company's quality system.
- BS or advanced degree in technical discipline
- 5+ years overall medical device experience
- 5+ years experience in quality assurance or engineering function
- 2+ years complaint handling experience including initiation through closure.
- 2+ years independent post-market regulatory reporting experience (MDR and/or Vigilance), drafting and submitting.
- Experience with Quality Systems as outlined in CFR820/ ISO13485
- Experience with utilizing a risk based approach to quality systems processes
- Demonstrated technical expertise and leadership in quality
- Strong ability to communicate (written and verbally) within and across disciplines and organizational structures.
- Demonstrated use of Quality tools and methodologies
- High attention to detail, organization and accuracy
Surmodics offers a competitive compensation and benefits package, including a bonus program, 401(k) with employer match, employee stock purchase plan and stock options.
Surmodics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.