Quality/Validation Engineer

TEAM continues to grow in the oral and healthcare markets and we are seeking individuals that want to grow with us! Position details are below:

The Quality Engineer is involved with new product introductions (NPI) as well as support of existing products that have already been commercialized. This position requires a well-organized, detail-oriented, hands on engineer to support Quality, Manufacturing, and Engineering. The Quality Engineer must help maintain TEAM’s Quality Management System in accordance with FDA Regulations (21 CFR 820 and/or 21 CFR 210-211) and ISO standards (ISO 13485, ISO 9001).

Supervise, train, and assist personnel with TEAMs systems and procedures. Play a leading role in DOE and pre-validation activities, equipment qualifications (IQ/OQ/PQ), complaint resolutions, CAPA’s, and related monitoring systems.

Job Responsibilities:

  • Assist in the development, implementation, and strict adherence to TEAM’s Quality Management System
  • Develop and execute DOE’s and pre-validation activities
  • Lead the maintenance and assist with the development of PFMEA’s
  • Lead the development and maintenance of Quality/Control Plans
  • Create or support the Validation team with writing qualification protocols and reports with input from Engineering, Operations, and relevant SME’s
  • Assist with internal non-conformities and complaint investigations
  • Lead Root Cause investigations and CAPA process using various quality tools (8D, why-why, fishbone, etc.)
  • Provide CAPA responses for customer issues and audit findings
  • Perform Gage R&R’s, MSA’s, and write test/inspection methods and procedures
  • Monitor and report KPI’s
  • Develops/reviews standards, policies, and procedures in support of DHF’s and DMR’s
  • Directs quality related activities in support of the Project Management Office (PMO), Manufacturing, Engineering, Purchasing, and Commercialization
  • Supports Operations with Engineering changes
  • Supports Quality and Regulatory to meet quality objectives

Qualifications/Skills Required:

  • Experience in quality management systems (i.e. ISO 13485, 9001)
  • Computer literate, including statistical processing software such as Minitab
  • Statistical Process Controls
  • Ability to work as a team member with multiple departments, and build relationships with internal and external suppliers and customers
  • Ability to work independently with little oversight

Education/Experience Required:

  • Bachelor’s in an Engineering discipline, preferred
  • CQE, highly preferred
  • Minimum 3 years’ experience in Quality or Engineering discipline
  • Prior experience working in an FDA regulated environment, medical device experience highly preferred

Physical Demands/Working Conditions:

  • While performing the duties of this job, employee is regularly required to walk, stand, and bend.  Must be able to sustain posture in seated position, with prolonged periods of intense attentiveness to computer use.  Hand and eye coordination and fine manipulation skills are necessary to operate computers and various office machinery.  Requires good listening and communication skills.  Job is physically comfortable
  • This is a salaried position requiring at least 40 hours per week.
  • Travel, up to 15%.

We are an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.