The Position
This position provides medical device and combination product quality assurance support at Arrowhead, with two areas of accountability: serving as the internal subject matter expert for medical device quality across the QMS and owning the product complaint management process for clinical and commercial combination products.
This position will report to the Director, Supplier Quality and works closely with members of Quality, Operations, Supply Chain, Regulatory, and Commercial teams, as well as external stakeholders and suppliers. This position will ensure clinical and commercial product quality remain in compliance with applicable US and international medical device regulations, standards and guidance.
This role is full-time onsite, 5 days a week in Verona, WI.
Responsibilities
Medical Device Quality
- Serve as an internal medical device SME, both US and ROW, for all relevant elements of QMS and quality of combination product development and commercialization, assuring proper integration and support of device regulations, including, but not limited to Change Management, Risk Management, DHF/DMR Maintenance, Internal Audits.
- Monitor, guide, and ensure internal stakeholders' decision-making and actions are consistent with 21 CFR 820, 21 CFR 4, ISO 13485, ISO 14971, Good Distribution Practices (GDP), relevant international regulations and guidance, and Arrowhead policies and procedures.
- Develop, define, support, review, augment, and/or approve a variety of controlled documents to ensure adherence to Medical Device Regulations and requirements.
- Provide quality guidance to project teams throughout design control, risk management, human factors engineering, process development, verification and validation testing, packaging, and distribution, as well as lifecycle management of design changes and associated documentation
- Identify gaps in existing processes, as well as need for new processes. Collaborate with cross-functional teams to develop and implement solutions.
- Drive continuous improvement to the combination product QMS, monitoring and identifying areas for improvement.
- Review Clinical Study Plans that include device instructions.
Product Complaint Management
- Own the end-to-end product complaint process for clinical and commercial combination products: intake, triage, documentation, investigation, root cause analysis, response, and closure within committed timelines, and establish the product complaint process for international markets in advance of launch.
- Coordinate complaint investigations with suppliers, contract manufacturers, and internal functions, ensuring investigations are technically sound and conclusions are supported by evidence.
- Partner with Pharmacovigilance/Safety and Regulatory Affairs to evaluate complaints for reportability and support timely submission of MDRs, combination product postmarketing safety reports under 21 CFR Part 4 Subpart B, and international vigilance reports.
- Participate in the setup of reverse distribution for clinical and commercial product, including return authorization and routing, chain of custody, cold chain integrity for returned units, quarantine and segregation upon receipt, and disposition or destruction with supporting documentation.
- Trend and analyze complaint data, report metrics to management review, and escalate signals that warrant CAPA, field action, or health hazard evaluation.
- Maintain complaint handling procedures, training, and systems in an inspection-ready state; represent the complaint system during audits and regulatory inspections.
Requirements- BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry or equivalent
- Minimum of eight (8) years of Quality Assurance experience in medical device or drug-device combination product, including three (3) years with direct accountability for medical device QMS elements.
- Demonstrated experience with product complaint handling, including investigation and root cause analysis, reportability assessment, and closure of complaint records within regulated timeline.
- Knowledge of GxP, focus on QMSR, 21 CFR Part 4, 21 CFR Part 803, ICH, EU MDR, ISO 13485, ISO 14971, and Good Distribution Practices.
- Experience applying design controls and risk management to devices or combination products, including DHF and DMR documentation.
- Works independently, is organized, can multi-task and adjust priorities in a fast-paced, dynamic work environment.
- Well-developed communication and interpersonal skills, with the ability to influence stakeholders at all levels.
- Organized, priority-setting, effective written and verbal communication.
- Ability to consistently communicate with external parties in a professional manner.
- Competent knowledge of and ability to use Microsoft Word, Excel, Adobe Acrobat, DocuSign, SharePoint and SmartSheet.
- Ability for occasional business
Wisconsin pay range
$150,000-$165,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
