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Quality Systems Engineer

  • Location: Hopkinton, Middlesex, Massachusetts
  • Salary: 25-29 per hour
  • Job Type:Contract

Posted about 1 month ago

  • Sector: Engineering
  • Start Date: 2021-08-16
  • Job Ref: 21-16150
Location - Can work Remote, will work east coast hours

Schedule - 40 hours Monday-Friday standard business hours.

Purpose of the main job
As a Complaint Handling Specialist, you will be a valued team member of Global Quality Systems supporting PerkinElmer global entities with complaint handling activities. In this role you will process product complaints per PerkinElmer global and site level procedures in alignment with applicable standards and regulations.

Main responsibilities
Develop subject matter expertise in multiple PerkinElmer complaint handling systems and processes to support PerkinElmer global entities
Edit and Review each complaint, including to determine eligibility for adverse event reporting or escalation.
Evaluate and track complaints through complaint process workflow to closure
Coordinate complaint closures per established business metrics.
Ensure completeness of complaint files prior to closure
Coordinate with team members in obtaining any missing information.
Collaborate with a variety of diverse persons such as Engineers, Scientists, Clinical Specialists, Field Service Engineers, Professional Customers and Manufacturing personnel to facilitate the complaint investigation process globally.
Assist with internal/external audits in support of complaint handling
Compile complaint trends for management reviews and support of product reliability reviews
Coordinate and compile department metrics to support management review meetings

Education - Bachelor Degree in Life Sciences or equivalent work experience
Required work experience related to position - Two to five years experience processing complaints in highly regulated medical device or biotech industry
Special requirements
Ability to work in a matrixed organizational structure, developing strong relationships with multi-national business partners
Exceptional attention to detail
Ability to take direction and multi-task in a fast-paced environment
Ability to work independently with minimal supervision
Strong data analysis skills and proficiency in electronic data management systems
Superior interpersonal, verbal and written communication skills
Exceptional organizational, negotiation, and problem-solving skills