Quality Engineer III - Sterilization

OMI Alpharetta Lab

Richmond, VA

Atlanta, GA

Tallahassee, FL

Mechanicsville, VA

Full time

_33647

Owens & Minor is a global healthcare solutions company providing essential products, services and technology solutions that support care delivery in leading hospitals, health systems and research centers around the world. For over 140 years, Owens & Minor has delivered comfort and confidence behind the scenes, so healthcare stays at the forefront, helping to make each day better for the hospitals, healthcare partners, and communities we serve.

Powered by more than 14,000 teammates worldwide, Owens & Minor exists because every day, everywhere,Life Takes Care™.

• 140+ years serving healthcare
• Over 14,000 teammates worldwide
• Serving healthcare partners in 80 countries
• Manufacturing facilities in the U.S., Honduras, Mexico, Thailand and Ireland
• 40+ distribution centers
• Portfolio of 300 propriety and branded product offerings
• 1,000 branded medical product suppliers
• 4,000 healthcare partners served

• Comprehensive Healthcare Plan -Medical, dental, and vision plans start on day one of employment for full-time teammates.
• Educational Assistance -We offer educationalassistanceto all eligible teammates enrolled in an approved, accredited collegiate program.
• Employer-Paid Life Insurance and Disability -We offer employer-paid life insurance and disability coverage.
• Voluntary Supplemental Programs -We offer additional options to secure your financial future including supplemental life, hospitalization, critical illness, and other insurance programs.
• Support for your Growing Family -Adoption assistance, fertility benefits (in medical plan) and parental leave are available for teammates planning for a family.
• Health Savings Account (HSA) and
  401(k) -We offer these voluntary financial programs to help teammates prepare for their future, as well as other voluntary benefits.
• Paid Leave -In addition to sick days and short-term leave, we offer holidays, vacation days, personal days, andadditionaltypes of leave - including parental leave.
• Well-Being -Also included in our offering is a Teammate Assistance Program (TAP), Calm Health, Cancer Resources Services, and discount programs - all at no cost to you.

The compensation for this position will be between $100,000 - $120,000 annually. Actual compensation will be based on applicable experience and education/training.

The Quality Engineer III, Sterility Assurance and Environmental Controls provides specialized technical expertise in terminal sterilization, sterility assurance, environmental controls, and related validation activities supporting medical products and manufacturing operations. The role independently executes complex technical work, supports investigations and compliance activities, and partners across functions to ensure sterilization processes and controls meet applicable Quality, regulatory, and business requirements. The position may lead defined technical projects and provides guidance within its area of expertise.

• Provides technical expertise in terminal sterilization, sterility assurance, environmental controls, and related Quality-system requirements for medical products.
• Develops, coordinates, and executes sterilization validation and qualification activities involving ethylene oxide, gamma irradiation, electron-beam irradiation, and other applicable sterilization technologies.
• Supports new-product development and product or material changes by evaluating sterilization requirements, material compatibility, microbial controls, validation requirements, and technical risks.
• Develops and executes technical protocols, validation plans, reports, specifications, and other documentation required to support sterilization processes and product compliance.
• Coordinates qualification activities for contract sterilization facilities and supports validation of selected sterilization processes.
• Ensures sterilization validation and qualification activities comply with applicable internal requirements, international standards, regulatory expectations, and Quality-system procedures.
• Provides technical support for existing validated sterilization processes, including requalification, revalidation, process changes, product changes, and routine maintenance activities.
• Evaluates product, material, packaging, manufacturing, and process changes to determine potential impacts to sterilization requirements and validated conditions.
• Supports change-control activities by…