Quality Engineer I

At Owens & Minor, we are a critical part of the healthcare process. As a Fortune 500 company with 50+ facilities across the US and 18,000 teammates in over 90 countries, we provide integrated technologies, products and services across the full continuum of care.

Customers and their patients are at the heart of what we do.

Our mission is to empower our customers to advance healthcare, and our success starts with our teammates.

Owens & Minor teammate benefits include :

• Medical, dental, and vision insurance, available on first working day
• 401(k), eligibility after 30 days of employment
• Employee stock purchase plan
• Tuition reimbursement
• Development opportunities to grow your career with a global company

POSITION SUMMARY

The purpose of this position is to provide tactical support with on-going activities required to support existing products within the North America DC Network of Owens & Minor.

These activities include but are not limited to providing DC QA oversight for Owens & Minor, overseeing the re-pack / re-box operations, conducting investigations as a result of quality related issues, maintaining accountability of non-conforming product and driving continuous improvement in the assigned DCs.

He / she provides technical / tactical support within Owens & Minor by embracing the goals and vision of the Senior Leaders, supporting various business strategies and new product launches.

He / she provides protection to technologies and products through appropriate use of patents and trade secrets .

RESPONSIBILITIES

1) Ensure that all elements of the corporate Human Resources Development and Diversity policy are fully supported as appropriate for the position.

2) Manages self in accordance with the expected behaviors of the Leadership Qualities.

3) Provides support in solving challenging technical problems related to quality issues and technologies.

4) Provides support in the development and implementation of new quality concepts, tools and strategies to improve business practices.

• Maintain control of all non-conforming products located at the assigned DCs.
• Conduct random cycle counts of non-conforming product to ensure 100% accountability.
• Support all new product launches for Owens & Minor.
• Help to drive continuous improvement at the assigned DCs by conducting Procedure / Process Flow Audits, and Failure Mode / Gap Analysis.
• Provide QA oversight for Owens & Minor in support of reboxing, kit packing, and product returns at the assigned DCs.
• Actively participate in the closure of corrective and preventive actions.
• Oversee and participate in the execution of protocols.
• Meet all training requirements and effectiveness criteria.
• Enhances department reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.
• Assist with the development, implementation and maintenance of Owens & Minor Distribution Quality Metrics.
• Conduct employee training audits to ensure employees are trained and qualified on all assigned tasks.
• Optimize key relationships with all levels of management within Operations Quality, Product Supply, and Distribution Network.

5) Performs other duties as assigned.

EDUCATION & EXPERIENCE

• Bachelor’s degree (B.S.) in Engineering or Science related field required
• Up to three (3) or more of quality engineering experience in a manufacturing environment preferred
• American Society for Quality (CQA, CQBA, CQE, CQM / OE) and / or Regulatory Affairs Professionals Society or comparable certification preferred
• Any combination of education and experience to meet the above requirements will be considered

KNOWLEDGE, SKILLS, & ABILITIES

• Limited knowledge of quality engineering / quality control principles; basic knowledge of statistics, Minitab and / or other statistical software experience
• Experience in a medical device manufacturing environment preferred
• Medical Device experience, knowledge of 21 CFR Part 820, (ISO 13485 a plus) preferred
• Basic understanding of Title 21 Code of Federal Regulations and other Federal and State regulations applicable to O&M's activities
• Working knowledge of electronic quality / regulatory software a plus
• Ability to work independently and as part of a team
• Possesses basic oral and written communication skills.; basic interpersonal skills
• Basic analytical capabilities with demonstrated skill in evaluating reports, identifying issues, noting trends, and reporting to these observations to management
• Must be able to analyze and define problems, collect data, establish facts and draw conclusions potentially with assistance from senior members of team

ADDITIONAL REQUIREMENTS

Ability to travel on a limited basis, up to 15%