Sr Quality Engineer – Medical Device

Job Title: Sr Quality Engineer – Medical Device

Job Location: North Haven, Connecticut (Fully onsite)

Type: W2 contract

Job Description -

Technical skills that are required for the role:

Risk Management (Hazard Analysis, DFMEA, UFMEA)

Design Verification Authoring and Execution

General NPD QE skillset. (Change control, CAPA, Iso 13485 understanding)

Education Required: Bachelor's of Engineering, Years’ Experience Required: 4

POSITION RESPONSIBILITIES MAY INCLUDE THE FOLLOWING, AND OTHER DUTIES MAY BE

ASSIGNED:

Actively participate in the product development cycle by reviewing mechanical/electromechanical

project documentation, participating in product risk assessments, and working

closely with Product Development to develop appropriate verification and validation testing

requirements.

Assesses overall product risk by facilitating the development of risk management

tools such as the risk management plan/report, hazard identification, risk analysis chart,

complaint analysis, etc.

Collect, analyze, and interpret statistical data. Performs analyses and provides reports

to management as required.

Contributes to the successful completion of Design and Process Validation initiatives

by planning/reviewing validation and qualification activities, as required. This may include

oversight to System/Sub-system Requirements, Critical to Quality Matrix, Process Flows,

Control Plans, Measurement Systems Analyses, and Process Capability Analyses.

Assisting with projects and assuring proper and consistent implementation of the

quality engineering tools.

Provide solutions to a wide range of difficult challenges. Work independently to

determine and develop solutions that are imaginative, thorough, practicable, and consistent

with organizational objectives.

Embedded Responsibilities:

Excellent organizational and communication (oral and written) skills. Ability to work on

teams as well as individually. Able to set and meet goals. Organized and detail-oriented.

Problem-solving and analysis skills.

BASIC QUALIFICATIONS:

MUST HAVE: MINIMUM REQUIREMENTS:

EDUCATION REQUIRED:

B.S. degree in Engineering, Math, Physical Science, or equivalent field with 5 years of

work experience in engineering or Quality

Preferred: M.S. degree in Engineering, Math, Physical Science, or equivalent field with

4 years of work experience in engineering or Quality YEARS OF EXPERIENCE:

Nice to Have: 6 years of experience in a regulated industry (2 years of experience

can be substituted for an Advanced degree in a related discipline.

Specialized skills or experience:

Fundamental understanding of electro-mechanical designs and manufacturing

processes to support designing, troubleshooting, improving, and qualifying the design to

ensure the sustainable manufacturing of medical devices, both internal and external.

Experience in a regulated industry

Experience with Minitab or similar statistical analysis tools

Experience with Risk Management Tools

Good interpersonal skills; Ability to work effectively in a team environment and build

strong working relationships.

Ability to work in a fast-paced environment; Ability to work well under pressure and

maintain a positive, enthusiastic attitude

Strong attention to detail and accuracy. Ability to successfully balance and prioritize

multiple ongoing projects/tasks (Project Management skills).

High degree of initiative and self-motivation. Strong analytical skills and the ability to

solve problems through analytical reasoning.

Nice to have:

ASQ Certified Quality Engineering (CQE)

Knowledge of and experience in developing and manufacturing medical devices in

conformance with Quality System Regulations, ISO13485, 14971 and 60601 requirements

Understanding of software and hardware interface.