Manager Quality Assurance

Sterigenics U.S., LLC; Salem (MA); On-site; USD 92,000 - 149,000; Full time

Benefits offered by this job

Medical, Rx, Dental, Vision, Disabilit

401(k) with Company match

Paid holidays, vacation and sick time

Parental leave

Education assistance

EAP

Job summary

Sotera Health is seeking a Quality Assurance Manager to lead the QA program at the facility and ensure regulatory and corporate compliance. You will coordinate audits, drive process improvements, and manage quality records and training across the site.

Reporting to the General Manager, you will oversee change control, data reporting to regulators, and QA-related personnel, with responsibilities spanning FDA, ISO, and customer requirements.

Qualifications

• BA or BS in a related field.
• 3–5 years of QA experience in medical services/products or extensive quality science training (ASQ).
• Food industry QA experience is desirable (for food irradiation facilities).
• Excellent written and verbal communication skills.
• Above average computer skills.

Responsibilities

• Maintain quality, regulatory and safety compliance across the facility.
• Coordinate audits with FDA, ISO, customer and regulatory bodies; drive corrective actions.
• Lead change control processes and data analysis for quality improvements.
• Maintain quality records, training programs and dosimetry/validation activities.
• Supervise QA-related activities and mentor staff as required.

Skills

Quality assurance

Regulatory compliance

Leadership

Written & verbal communication

Computer skills

Education

BA/BS in related field

Tools

ASQ training

Job description

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year.

Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

Reporting to the General Manager, the Quality Assurance (QA) Manager is directly responsible for managing and coordinating all quality functions for the facility. He/She maintains responsibility for all aspects connected with compliance, including the development, analysis and reporting of support data for regulatory agencies and Corporate Quality. In addition, he/she is responsible for addressing all quality issues in a timely fashion and communicating that information to the site as required. The Quality Assurance Manager is responsible to assure compliance with all corporate and government procedures and regulations and serves as the Management Representative and Responsible Engineering Manager for the facility.

Responsibilities

• Quality, Regulatory & Safety
• Maintains compliance with all regulatory requirements to include: FDA, OSHA, EPA, USDA and NRC as applicable.
• Actively pursues continuous process and quality improvement as measured by internal indices and external audits/reports.
• Coordinates activities relating to determining and reporting causes of non-conformances, as well as implementing corrective actions and process improvements; assist in appropriate retraining.
• Initiates and/or oversees change control process.
• Analysis of facility data for identification of trends and initiation of required actions.
• Coordinates all activities relevant to FDA, ISO, customer, Internal & other regulatory audits.
• Conducts internal compliance audits as required and maintains appropriate records.
• Maintains facility quality records and procedures.
• Coordinates and maintains personnel dosimetry records.
• Coordinates with plant Operations all system requalification activities as applicable.
• Assists Corporate Quality Assurance with special projects and assignments as requested.
• Coordinates facility management reviews.
• Coordinates and maintains facility risk analysis.
• Coordinates environmental monitoring and maintains personnel badge testing records.
• Executes Equivalency and Retrospective Revalidation studies/report where applicable.

Operations

• Coordinates/executes process validations and calibrations where required.
• Reviews and releases batch records for processed materials.
• Assists where necessary in establishing departmental objectives to meet overall facility goals.

Human Resources

• Communicates the company quality policy and values, motivating and sensitizing employees to the critical nature of our service.
• Involved in the hiring, retention, motivation and development of qualified personnel in QA/Validations positions, if applicable.
• Assists with new employee orientation, job function, GMP, safety and developmental training to employees as required by Standard Operating Procedures, Certification programs, corporate requirements and customer service initiatives.
• Interacts with all functions within the plant.
• Provides all subordinates with clear and measurable objectives.
• Maintains all quality related training programs.
• Assists with other tasks as assigned by Supervisor.
• SUPERVISION GIVEN: May supervise the work of others.

Qualifications

• Minimum BA or BS in a related field
• Three (3) to five (5) years of quality assurance experience in the medical services/products area or, extensive quality science training (e.g., ASQ), with a proven understanding of people’s motivation and proven leadership potential.
• Comparable experience in the food industry is desirable (in lieu of medical experience) for food irradiation facilities.
• Excellent written and verbal communication skills.
• Above average computer skills.

Training Required

• Must complete all required training for a “Quality Assurance Manager” outlined in the training manual.

Benefits and Pay

Pay: $92,000–$149,000 annually, based on experience, qualifications, and skills.

Sotera Health offers a competitive benefits package that includes:

• Medical, Rx, Dental, Vision, Disability, Life Insurance, Health Savings and Flexible Spending Accounts
• 401(k) program with Company match that immediately vests
• Paid holidays, vacation and sick time
• Free financial planning assistance
• Paid parental leave
• Education assistance
• Voluntary benefits including Critical Illness, Accident, Hospital Indemnity and Pet Insurance
• Employee Assistance Program (EAP)

All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or protected veteran status. Sterigenics U.S. LLC takes affirmative action in support of its policy to employ and advance in employment individuals who are minorities, women, protected veterans, and individuals with disabilities. We strongly encourage those from underrepresented groups to apply.

VEVRAA Federal Contractor

Sotera Health goes to market through its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries.