Sr. Product Quality Complaint Specialist

Implantica; United States; À distance; USD 110 000 - 140 000; Plein temps

Résumé du poste

Implantica is seeking a Sr. Product Quality Complaint Specialist to manage timely and thorough investigations of medical device complaints within an eQMS that meets regulatory requirements in regions where the business operates.

This role supports post‑market surveillance and cross‑functional collaboration in a remote US setting. The ideal candidate has 4+ years in Quality/PMS for medical devices, a clinical/medical degree, and strong knowledge of 21 CFR Part 820, MDR, ISO 13485, and MDSAP.

Qualifications

• Demonstrated experience in Quality/PMS within medical devices.
• Prerequisite degree in clinical/medical services (ADN/BSN/RN/NP/MD).
• Experience with US regulatory requirements (FDA/ISO).
• Familiarity with QMS software and data handling.

Responsabilités

• Lead complaint investigations and closure of records.
• Maintain electronic complaint database in compliant eQMS.
• Classify complaints and escalate for regulatory reporting where needed.
• Submit incident/adverse event reports timely.
• Communicate with clinicians, sales, and customers to gather details.
• Identify trends and initiate corrective actions as appropriate.

Connaissances

Quality mindset

Analytical thinking

Cross-functional collaboration

Written and verbal communication

Formation

Clinical/medical degree (ADN/BSN/RN/NP/MD)

Outils

QMS software

Microsoft Excel

Charting programs

Regulatory documentation

Description du poste

Implantica is a medtech company focused on bringing advanced implantable technologies into the body designed to improve patient outcomes and quality of life. The company’s lead product, RefluxStop®, is an FDA approved and CE-marked implant for the treatment of gastroesophageal reflux disease (GERD) with the potential to transform the standard of care in anti-reflux surgery, supported by strong long‑term clinical outcomes. In addition to RefluxStop®, Implantica has developed a broad, patent‑protected product pipeline partly incorporating two platform technologies: an eHealth platform designed to enable communication with and remote monitoring and control of implants inside the body, and a wireless energizing platform designed to wirelessly power implantable devices through intact skin. Implantica is listed on Nasdaq First North Premier Growth Market (ticker: IMP A SDB).

The Role:

We are seeking a Sr. Product Quality Complaint Specialist responsible for timely and accurate handling of complaint investigations and closure of complaint records including the management and maintenance of an electronic complaint database within an eQMS that is compliant with regulatory requirements in applicable regions in which the business is commercial. This position will provide you the opportunity to work in a multinational environment with the role remote‑based work in the U.S.

Applicants in the following states will be prioritized: California, Florida, Maryland, Minnesota, Missouri, Ohio, Oklahoma, Texas

Key responsibilities include:

• Deputy PRRC:15.3(c) and (d)
• Support the validation, implementation, management, and maintenance of an electronic complaint database within an eQMS that is compliant with regulatory requirements in applicable regions in which the business is commercial. Work with internal personnel to ensure that accurate information is fed into the system, maintained, and linked to downstream processes.
• Facilitate the timely and accurate handling of complaint investigations and closure of complaint records. Ensure issues are being addressed in a timely and compliant manner.
• Perform the preliminary classification of complaints and elevate complaints that require reporting for additional review.
• Responsible for timely submission of Incident/Adverse Event Reporting.
• Communicate with Clinicians, Sales/Marketing, and other internal or external customers to identify details related to complaint information and occurrence and obtain information required for complaint assessment and evaluation.
• Recognize complaint trends, potential product problems and potential recalls, and initiate immediate remedial action, if appropriate.

Post Market Surveillance Reporting Responsibilities:

• Actively collaborate with cross‑functional key stakeholders in support of post market surveillance plan/report creation to assess the safety, effectiveness, and performance of regulated products/devices.
• As part of a team, responsible for obtaining data from multiple sources including but not limited to: Complaints, Adverse Events, Recalls, Risk Management, CAPAs, Non‑conformances, Validations, Literature) and perform the required analysis in applicable data analysis tools (Excel, Minitab, or similar applications); utilize public databases for obtaining post market data on competing products for comparative analysis. Responsible for ensuring traceability, reproducibility, and consistency of the results generated.
• Responsible for reviewing data analysis with department management to detect emerging trends of such issues that may require action and escalation. Work closely with department management to continually seek to identify new feeder systems to effectively monitor product performance after launch.
• As part of a team, responsible for compiling data and preparing reports at periodic intervals as required by regulations.

Other Quality Responsibilities:

• Author, review, and/or approves change requests (CRs), CAPA plans and reports, Quality Plan(s), and other technical documents. Ensure records are well documented and conform to procedural requirements.
• Provides medical input and review for Risk Management, Health Hazard Evaluations (HHEs), and any necessary Field Actions/Recalls.
• Support Regulatory Audits/inspecitions as a Subject Matter Expert

Qualification and Skill Requirements

• 2 to 4‑year degree in clinical/medical services (ADN, BSN, RN, NP, or MD) and a minimum 4 years of related experience in Quality/PMS within a medical device organization.
• Demonstrated experience in Post Market Surveillance tasks.
• Demonstrated experience with QMS software and databases, plus the ability to read technical documents.
• Experience with US Class III devices and/or EU Class IIb devices strongly preferred.
• Excellent working knowledge on 21 CFR Part 820, 21 CFR Part 803 (MDR), and ISO 13485.
• Good working knowledge on MDSAP requirements.
• Be able to identify missing information, evaluate accuracy of the presented information.
• Demonstrates strong attention to detail.
• Strong ability to analyze complex data to identify patterns.
• Ability to work collaboratively across the organization with both internal and external teams and across different locations / time zones.
• Proficient with written and spoken English; strong written and verbal communication skills to interact with clinicians and users.
• Detail oriented and the ability to manage multiple activities simultaneously.
• Expertise in Microsoft Office applications and charting programs.
• Ability to travel internationally, as needed.