Quality Engineer II

Owens & Minor • Asheville, NC

6d • $75,000 - $80,000 • Onsite

About The Position

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™.

Global Reach with a Local Touch
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

The Quality Engineer uses their personal experience and judgment applying learned engineering methodologies and other analytics to initiate, implement, and manage the master validation plan within the facility. The Engineer will have responsibility for improving operational effectiveness through the refinement of existing procedures or business processes to optimize validations. The Quality Engineer will be a key resource for new product and machine validations providing subject matter expertise.

Requirements

• Bachelor’s degree (B.S.) in Engineering or other technical degree from a four-year college or university is required.
• Four to six years of experience in the Quality field is required.

Nice To Haves

• Three to five years of experience in a manufacturing environment preferred.
• Green/Black Belt Certification or Lean Manufacturing training preferred.
• Medical Device experience, knowledge of ISO 13485, sterilization, and Minitab experience a preferred.

Responsibilities

• Creates, manages and improves the Master Validation Plan; designs protocols that utilize proper sampling techniques, strong design of experiments and tests and will provide statistical rationale.
• Conducts validation or qualification tests on new or existing equipment, processes or software in accordance with internal protocols or external standards.
• Conducts sterilization validations in accordance with internal protocols and external standards.
• Supports activities related to the master sterilization plan.
• Develops and manages aging studies for packaging which may include coordinating testing, analyzing data and documenting results.
• Leverages various software programs such as Word, Excel, SAP, Minitab and other necessary programs or project tools to manage and analyze data and complete work.
• Provides analysis and interpretation of report data including the use of systems.
• Leads Risk Analysis.
• Responsible for KPI improvement on the production floor.
• SME for Change Control.
• Performs additional duties as directed

Benefits

• Comprehensive Healthcare Plan - Medical, dental, and vision plans start on day one of employment for full-time teammates.
• Educational Assistance - We offer educational assistance to 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, and additional types 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level