Medtronic je globalno podjetje na področju zdravstvenih tehnologij in proizvodnje, ki razvija rešitve za kompleksna zdravstvena stanja. Njegovo delo povezuje velike mednarodne ekipe in tesno sodelovanje z zdravstvenimi strokovnjaki za izboljšanje zdravljenja, terapij in dostopa do medicinske tehnologije. Z več kot 95.000 zaposlenimi v več kot 150 državah se Medtronic osredotoča na napredek pri oskrbi pacientov ter hkrati podpira vključevanje, raznolikost, enakost in trajnostne prakse v vseh svojih dejavnostih.
Senior Compliance Specialist, Medical Devices
Lead investigations, audits, and corrective actions while supporting quality-system and regulatory compliance for Medtronic’s medical-device operations. The role provides oversight to EU Surgical Operating Unit entities and requires about 25% domestic and international travel.
Opis
- Lead investigations and root-cause analysis, then drive corrective and preventive actions.
- Guide teams on quality systems and compliance with FDA and international regulations.
- Oversee the development and upkeep of quality systems, programs, processes, and procedures.
- Provide quality oversight to EU Surgical Operating Unit entities, including QMS processes, audits, certifications, production quality issues, PHO, and FCA support.
- Work with internal and external stakeholders to advance compliance program changes and execution.
- Escalate business issues and opportunities to the next level of management.
- Lead, coordinate, or prepare internal and external audits to meet regulatory standards.
- Analyze trends and report compliance observations to identify opportunities for improvement.
- Investigate and resolve compliance concerns, questions, and complaints from company units, customers, and government regulators.
- Keep policies and procedures current with applicable Quality, FDA medical-device, HIPAA, and ISO requirements, consulting policy experts as needed.
Zahteve
- Bachelor’s degree.
- At least 6 years of relevant experience, or an advanced degree and at least 4 years of relevant experience.
- Knowledge of quality-system elements and regulations for finished medical devices, including FDA, GMP, QSR, ISO 13485, and MDSAP.
- Ability to implement and communicate quality and regulatory requirements in a government-regulated healthcare industry.
- Knowledge of core QMS, design control, and manufacturing processes and requirements.
- Proficiency with data-analysis tools, analytical and research skills, and problem-solving methods.
- Strong attention to detail and ability to follow audit trails to identify risks, nonconformances, and root causes.
- Excellent written, verbal, and presentation skills.
- Sound judgment, independent decision-making, and demonstrated leadership ability.
- Ability to manage multiple critical projects and priorities at once and escalate issues when needed.
- For bachelor’s degrees earned outside the United States, the degree must meet the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).
- Unrestricted U.S. work authorization at hire and throughout employment.
- About 25% domestic and international travel.
- Preferred: 3 or more years of relevant experience in design and development and/or manufacturing.
- Preferred: Experience supporting or participating in regulatory inspections and audits.
Ugodnosti
- Competitive salary and flexible benefits package.
- Health, dental, and vision insurance.
- Health Savings Account.
- Healthcare Flexible Spending Account.
- Life insurance.
- Long-term disability leave.
- Dependent daycare spending account.
- Tuition assistance or reimbursement.
- Simple Steps global well-being program.
- Incentive plans.
- 401(k) plan with employer contribution and matching.
- Short-term disability.
- Paid time off.
- Paid holidays.
- Employee Stock Purchase Plan.
- Employee Assistance Program.
- Non-qualified Retirement Plan Supplement.
- Capital Accumulation Plan for vice presidents and above, or those meeting IRS earnings minimums.
- Temporary employees may receive paid sick time as required by state law and may participate in the Employee Stock Purchase Plan.