Quality Engineer I

Owens & Minor • Louisville, KY

21h • Onsite

About The Position

Supports and continuously improves the operations and quality system elements for the facility involved in the distribution, repackaging, relabeling, and value-added services for manufacturers of medical devices who contract Owens & Minor’s Outsourced Logistics business unit for 3PL services. Serves as quality contact for assigned areas of oversight and is accountable for all quality outputs for those respective areas. Supports defect reduction and problem resolution using a variety of investigative and analytical tools. The ideal candidate must be a critical thinker and open to working in a fast-paced environment that emphasizes detail, tactical, and process-improvement support. The individual will contribute to achieving the milestones and objectives for their assigned areas of responsibility.

Requirements

• Bachelor’s degree (B.S.) in Engineering or a Science related field required
• Microsoft Application experience with Word, Excel, PowerPoint, and Outlook required.
• Limited knowledge of quality engineering/quality control principles; basic knowledge of statistics a plus
• Basic understanding of Title 21 Code of Federal Regulations and other Federal and State regulations applicable to O&M's activities preferred
• 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

Nice To Haves

• Up to three (3) or more of quality engineering experience in a manufacturing or logistics environment preferred
• American Society for Quality (CQA, CQBA, CQE, CQM/OE) and/or Regulatory Affairs Professionals Society or comparable certification a plus
• Medical Device experience, knowledge of 21 CFR Part 820 and or ISO 13485 preferred
• Working knowledge of an electronic quality management system is a plus

Responsibilities

• Supports programs such as quality metrics, management reviews, cost of quality, training, risk management, change management and authoring and managing Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Supports operations to ensure compliance for the distribution, repackaging, relabeling, and containment of medical devices.
• Supports operations to define quality objectives for key performance indicators (KPIs).
• Supports the implementation of associated measurement systems and collects and monitors data for relevant trends of KPIs.
• Supports oversight of quality management system activities to ensure that Process Exceptions, Non-conformance, and CAPAs are opened as needed and are resolved in a timely and effective manner; supports root cause analysis through training and hands-on assistance.
• Supports validation or qualification tests of new or existing equipment, processes or software in accordance with internal protocols as applicable.
• Acts as the quality contact for 3PL client(s).
• Will be accountable for ensuring procedures and processes for receiving, storage, value added services (if applicable), and shipping are established and current for the client(s).

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