Title: Quality Assurance Technician

Location: New Haven MA - REQURIED ONSITE 5 DAYS PER WEEK - NEW HAVEN. PARKING WILL BE REIMBURSED.

Duration: 12 Months

You will be responsible for:

• Manage medical device test method and specification development, including test method development, validation, transfer, and life cycle management.

• Support the laboratory operation such as sample inventory, equipment qualification and maintenance.

• Conduct characterization for device function, assembly, manufacturability, etc. using both CAE and traditional engineering techniques.

• Test mechanical or electromechanical systems on bench top models or production representative units, during design development and verification.

• Consult with third parties such as specialist manufacturers and toolmakers.

• Communicate effectively, both verbally and in writing, internally across departments and with external suppliers.

• Comply with the Company’s quality assurance requirements as well as applicable regulatory requirements.

You will need to have:

• Experience in design control activities.

• Knowledge of primary containers and drug delivery.

• Understanding of mold, fixture design and build as well as application of validation processes (IQ/OQ/PQ).

• Interface with the medical device vendor and tooling company.

• Knowledge of the regulatory and compliance requirements of device design controls and combination products (i.e. FDA QSR 21 CFR Part 4 and 820/ISO13485 quality system requirements).

• The duties of this role are conducted in a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15-30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/de-gown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

• Bachelor’s degree in Engineering (Biomedical, Chemical, Mechanical, or Electrical Engineering) plus 1-to-3-year experience in laboratory.

Experience with injector-based combination product preferred.

Appendix B: Physical and Mental Requirements

The duties of this role are conducted in an lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.