2 дня назад
Senior Manager, Supplier Quality & Audits (Medical Devices)
136 000 - 187 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Senior Manager, Supplier Quality & Audits (Medical Devices): Leading divisional audit and supplier quality programs across global manufacturing sites and suppliers with an accent on regulatory compliance, risk-based auditing, and inspection readiness. Focus on overseeing auditor networks, managing supplier risks and remediation, and communicating quality performance to senior leadership.
Location: Deerfield, Illinois, United States. Travel up to 50%, including domestic and international travel.
Salary: $136,000–$187,000 annually, with potential discretionary bonuses.
Company
is a healthcare company focused on medical products, patient safety, regulatory compliance, and improving healthcare delivery.
What you will do
- Lead the divisional internal audit strategy, planning, execution oversight, reporting, and governance across manufacturing, compounding, and design sites.
- Monitor audit results, compliance trends, quality risks, and inspection outcomes to support risk-based quality decisions.
- Oversee the global auditor network, including qualification, development, and program effectiveness.
- Lead supplier quality programs covering supplier risk management, performance monitoring, quality issues, and remediation.
- Partner with Quality, Regulatory Affairs, Procurement, Manufacturing, Operations, and site leaders on inspection readiness and compliance improvements.
- Develop teams and communicate program performance, risks, and priorities to senior and executive leadership.
Requirements
- Bachelor’s degree in Life Sciences, Engineering, or a related technical field.
- 10+ years of experience in Quality, Regulatory Affairs, Manufacturing, or a related regulated industry, including 7+ years of leadership experience and 5+ years of auditing experience.
- Prior medical device industry experience is required.
- Strong knowledge of global medical device manufacturing regulations and experience with regulatory inspections, including FDA inspections.
- Experience leading large-scale quality, compliance, regulatory, or manufacturing organizations and managing complex compliance issues, risk assessments, and quality improvement initiatives.
- Applicants must be authorized to work for any employer in the United States; visa sponsorship is not available.
Nice to have
- Experience in pharmaceutical and/or biologics manufacturing environments.
- Familiarity with pharmaceutical and biologics regulations.
Culture & Benefits
- Collaborative quality organization focused on patient safety, compliance, and operational excellence.
- Medical and dental coverage beginning on the first day.
- Life, disability, and business travel accident insurance.
- 401(k) retirement plan, employee stock purchase plan, flexible spending accounts, and educational assistance.
- Paid holidays, 20–35 days of paid time off based on length of service, family and medical leave, and paid parental leave.
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