Quality Engineer

Quality Engineer

Kelly Services is currently seeking a Quality Engineer for one of our top clients in either Raynham, MA or West Chester, PA.

We are seeking a Quality Engineer to support general lab quality and lab validation activities in a regulated medical device laboratory. This role will be part of a global lab compliance team and responsible for supporting and the completion of quality deliverables within the laboratory including Audit, CAPA, and Nonconformance investigation and management to meet quality performance measures established by the business.

This role will partner with Test Engineers, R&D Engineers, Compliance/ Quality Engineers, Quality Systems, and other functions to complete activities.

• Responsible for supporting overall quality system execution for assigned laboratory teams with oversight. This includes quality system metrics such as nonconformance timeliness and aging, CAPA timeliness and aging, and Audit observation timeliness and aging.
• Responsible for nonconformances, CAPA, and audit observations, including execution corresponding actions, for assigned laboratory teams with oversight and within the required time.
• Responsible, with oversight, for Quality review of documentation including test methods and TM validations, Instrument and software validations.
• Responsible, with oversight, review/approval of calibration/maintenance records.

• Minimum 2 years’ experience in a regulated industry.
• Bachelor’s degree required, preferably in Engineering, Science, IT or related field.
• Excellent technical writing skills and attention to detail.
• Excellent problem analyzing and solving.
• Ability to effectively work on multiple tasks.

• Medical device laboratory experience is preferred.
• Knowledge of regulatory guidelines is preferred.
• Experience with ETQ.

• Hybrid working — 3 days onsite.
• Raynham, US/ West Chester, US / Leeds, UK based, preferably Raynham or West Chester for US time zone.

This position is recruited by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States.

• Vacation and sick pay
• Paid holidays
• 401(k) plan
• Group medical, vision, dental, life, and short-term disability insurance options
• Kelly Discounts on goods and services, auto and home insurance, and tuition at Kelly partner schools
• Kelly Learning Center offers free courses and trainings
• Weekly pay

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.