Senior Manager, Quality

Assumes overall responsibility for ensuring site(s)/operations maintain operational and quality systems in compliance with domestic and international standards, including ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137, ISO 11135, and other applicable regulatory standards. Oversees quality system execution across multiple facilities, modalities, and technologies (e.g., laboratories, radiation technology centers, dosimeter manufacturing, e-beam system manufacturing, calibration cells) in a heavily regulated environment.

Responsibilities

• Lead and direct Quality Operations Leads and staff for assigned facilities within country/multiple countries, ensuring compliance with the Quality Management System and driving continuous improvement.
• Ensure product release is executed per approved Work Instructions and Customer specifications.
• Align Operational Quality activities with AST organizational goals through implementation of improvements directed by senior leadership.
• Accountable for metric performance in assigned region, including identifying and leading countermeasure activities for sites not meeting monthly key performance targets.
• Coach, manage, and monitor staff through performance feedback, formal reviews, and development initiatives.
• Ensure required initial and continuing training of Quality Operations personnel is implemented.
• Provide direction to Quality Operations Managers, Leads, Engineers/Analysts, and Technicians to implement quality system standards.
• Monitor facility non-conformances, Customer complaints, and audit findings from internal and external audits; perform periodic audits within assigned facilities.
• Own the Customer and notified body quality/regulatory audit process at assigned facilities, including developing sustainable remediation action plans.
• Collaborate with Operations Management to identify opportunities for improvement and efficiency while ensuring regulatory compliance.
• Lead support during Regulatory inspections, including gathering Inspector’s requests for information and implementing remediation as required.
• Direct implementation of Dosimetry or Biological Indicator systems/manufacturing (where applicable) to ensure compliance with regulations.
• Co-own continuous improvement efforts with Operations by participating in quality and performance improvement projects.
• Monitor Operational Quality facility expenses to ensure alignment with budgets and forecasts.
• Promote a safe, clean, and secure working environment by supporting safety procedures and committees.
• Uphold STERIS Code of Business Conduct and comply with all Company policies.
• Protect company confidential information through proper handling and dissemination.
• Exhibit commitment to AST shared values of Customer Satisfaction and Continuous Improvement.
• Perform other duties as assigned.

Requirements

• Bachelor’s Degree (Engineering or related technical field).
• Minimum 10 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
• Minimum 10 years of experience working in an ISO certified environment.
• Minimum 6 years in a Quality leadership role with direct supervisory responsibilities.

Preferred Qualifications

• Minimum 10 years of experience with medical device or other regulated industries.
• Experience managing employees in multiple facilities/countries/geographies.
• Sterilization experience.
• Strong working knowledge of FDA QSR/EUGMP regulations.
• Excellent problem-solving skills with a focus on continuous improvement.
• Experience working on cross-functional teams and independently under minimal supervision.
• Effective interpersonal, organizational, oral, and written communication skills.
• Proficiency in PC applications including Excel, Word, and PowerPoint.
• Ability to work in a fast-paced, regulated environment with strict deadlines.
• Mathematical skills including practical application of fractions, percentages, ratios, proportions, and algebra.

Benefits

• Market competitive pay.
• Extensive paid time off and 9 added holidays.
• Comprehensive healthcare, dental, and vision benefits.
• Long/short term disability coverage.
• 401(K) with company match.
• Maternity and parental leave.
• Additional benefits/discounts (e.g., pet insurance).
• Tuition reimbursement and continued educational programs.
• Opportunities for advancement in a stable, long-term career.

Pay

Pay range for this opportunity is $115,000 - $140,000. This position is eligible for bonus participation. Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on factors including local labor market costs, years of relevant experience, education, professional certifications, and foreign language fluency.