Medtronic — күрделі медициналық жағдайларға арналған шешімдер әзірлейтін жаһандық денсаулық сақтау технологиялары және өндіріс компаниясы. Оның қызметі емдеу тәсілдерін, терапияларды және медициналық технологияларға қолжетімділікті жақсарту үшін ірі халықаралық командаларды медицина мамандарымен тығыз ынтымақтастықта біріктіреді. 150-ден астам елде 95 000-нан көп қызметкері бар Medtronic пациенттерге көрсетілетін көмекті дамытуға назар аудара отырып, өз қызметінің барлық бағыттарында инклюзияны, әртүрлілікті, теңдікті және тұрақты тәжірибелерді қолдайды.
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.
Сипаттама
- 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.
Талаптар
- 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.
Артықшылықтар
- 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.