QUALITY ASSURANCE ENGINEER | LEBANON, TN

Responsible for the direct support of manufacturing operations on the shop floor; ensures quality and consistency of products by establishing product inspection criteria and methods; monitoring internal product quality; working with appropriate parties to improve product quality; and analyzing and reporting on quality data.

PROVIDES QUALITY SUPPORT TO OPERATIONS BY: Investigating non-conforming material and determining its disposition; determining characteristics critical to quality and safety based on product drawings, risk management documentation and feedback from appropriate departments; determining acceptance criteria and inspection methods and frequency for raw goods, components, and finished products; assessing the impact of uncalibrated or out of tolerance measuring equipment; and utilizing appropriate standards for determination of sample size and frequency. Investigates customer complaints and analyzes complaint trends to determine if corrective actions are required.

IDENTIFIES AND MITIGATES RISK BY: Understanding how requirements laid out in ISO 14971 and government regulations for risk management apply to company products and processes; supporting formal risk management activities as a member of the risk team; and utilizing risk management tools such as FMEA, Hazard Traceability Matrix, Fault Tree Analysis, and Root Cause Analysis.

SUPPORTS IMPROVEMENTS By: Managing and analyzing data for products; tracking the impact of product and process changes on product quality; participating in Lean and Six Sigma activities, Kaizen events, and other improvement initiatives; presenting reports to appropriate department managers; and providing feedback to leadership.

SUPPORTS REGULATORY COMPLIANCE BY: Identifying and educating others on regulations and standards applicable to the product and manufacturing process; evaluating processes, change requests, and deviations against regulatory requirements; and supporting internal and external audits.

TAKES FULL QUALITY OWNERSHIP BY: Monitoring and reporting on Production Line quality including but not limited to quality of components, quality performance of products manufactured on production lines; Coordinating improvements with operations supervision; communicating external supplier nonconformities to Group Supply Chain for resolution; and managing quality of internal suppliers. Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with a variety of abstract and concrete variables. Solid understanding of statistical techniques.

Requirements:

• Bachelor’s degree in engineering or Scientific discipline is strongly preferred

• 2+ years related experience.

• Ability to use independent judgement with minimal guidance to achieve objectives of assignments, operating within specific policy and department guidelines.

• Professional certification may complement a non-Engineering degree.

• Familiarity with medical device regulations – 21 CFR Part 820 and ISO 13485 preferred.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.