Quality Engineer I

Owens & Minor • Toano, GA

1d • 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™. Reports to the Quality Assurance Manager and is responsible for assuring compliance with the Quality Management System (QMS) by coordinating and maintaining quality systems related to Environmental Monitoring, Pest Control, Calibration, Preventive Maintenance oversight, Master Validation Plan (MVP), and Sterility Assurance support. This position supports medical device manufacturing with a primary focus on Custom Procedure Trays (kitting operations) and ensures compliance with applicable regulatory and international standards including FDA 21 CFR Part 820, ISO 13485, and applicable sterilization standards. The QA Engineer I works cross-functionally with Maintenance, Sterility Assurance, Manufacturing, and Engineering to maintain validated states and system robustness. The incumbent applies quality engineering principles to support sterilization process validations, requalification’s, and evaluations, ensuring the continued effectiveness of sterile barrier systems and sterilization controls. The anticipated salary for this position is $70,000 annually. The actual compensation offered may vary based on job related factors such as experience, skills, education and location. This position is onsite in Toano, Virginia. Scope The scope of this position applies to the assigned manufacturing facility and all quality systems supporting sterile medical device production, including validation-related and environmental control processes.

Requirements

• Bachelors degree in Engineering or equivalent experience
• 3 to 5 years on manufacturing environments
• At least 1 year of experience on highly regulated industry (preferable FDA regulated products)
• At least 1 year of experience on leading teams
• Knowledge of calibration, pest control and environmental controls programs
• Proven skills on Problem solving techniques
• High knowledge on developing and technical documents and reports Interpretation of documents
• Deep knowledge on sampling plans for product release
• Ability to apply statistical techniques to analyze data, prepare reports and identify opportunities for improvement
• Proven success leading and coordinating cross functional teams
• Proficient in MS Excel Statistics (at least Basic quality control tools).
• ISO 13485 and 21 CFR part 820.
• Industrial engineering.
• AQL or similar sampling systems.

Nice To Haves

• Training on lean six-sigma
• ISO 13485 Internal auditor training and 21 CFR 820 (preferred)

Responsibilities

• Ensure compliance on operation with the requirements of quality standards and regulations (FDA, ISO-13485, MDSAP,) according to established policies and procedures.
• Conducts validation or qualification tests on new or existing equipment, processes or software in accordance with internal protocols or external standards.
• 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.
• Participate in sterilization validations and requalification’s in accordance with internal protocols and external standards.
• Leverages various software programs such as Microsoft Office as Word, Excel, PowerPoint, ERP systems, Minitab and other necessary programs or project tools to manage and analyze data and complete work.
• Assure AQL standard compliance (Lab/Manufacturing).
• Resolve quality issues at manufacturing site.
• Oversee Label Room equipment and laboratory equipment.
• Perform internal audits as needed.
• Host/support during External Audit.
• Coordinate, review, and apply materials and process inspection methods using approved procedures to ensure quality at all stages of manufacturing.
• Timely implementation of Change Request action Items.
• Develop, control and coordinate QA Alerts in manufacturing areas
• Assure compliance with Document control process requirements and record retention process.
• Coordinate and control calibration and test equipment based on requirements to ensure that tests are performed with reliable standards-based measurements.
• Control and plan preventive maintenance schedule working with maintenance department.
• Coordinate and follow the requirements of environmental monitoring procedure and policy, executing environmental program.
• Investigate and develop action plan to resolve Out Of Specification related to environmental Laboratory analysis results.
• Oversee Pest control program and implement control measures to avoid pest contamination.
• Identify the need for corrective/preventive actions and ensure timely execution as per established procedures.
• Investigate and collaborate with the cross functional team to address customer complaints using the established complaints system to keep customer responses on time and in order.
• Use statistical tools to monitor Quality Systems
• Provide the necessary training for all the personnel involved, maintain the training needs system of the Quality Department in force.
• Activities related to Environment (E), health (H) and safety (S), Hygiene and Environmental Control Responsible to report and assure safety of QA related areas following the best practices and Environment (E), health (H) and safety (S) (EHS) guidelines
• Participate and coordinate EHS investigations of accident or incidents for assignable QA areas.
• Participate on BBS Safety observation program

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: Entry Level
• Number of Employees: 5,001-10,000 employees