Quality Engineer I

Job Title: Quality Engineer I
Job ID: 23543
Duration:24 Months
Location: 195 McDermott Rd North Haven Connecticut 06473
Pay Rate: $35.00 - 40.00/hr

JOB DESCRIPTION
What is the business title? Quality Engineer I
Where is the work to be performed? (Please list preferred Health Care Company facility, if other please specify i.e. remote work, rural, etc.) North Haven, CT (on site min 4 days per week)
Can you please provide a summary of the project/initiative which describes what's being done? NPD Quality - Development of Risk Management files and Design History files for new Surgical products
What does the team make-up look like - how many members and what is the break-down of the team's skill sets (ex: 1 PM, 4 Developers, etc.)? 16 Quality Engineers ranging from Principal to QEII
What are the top 5 responsibilities for this position? (Please be detailed as to what the candidate is expected to do or complete on a daily basis)
Creation/Maintenance of Risk Management files for new products - Preliminary Hazard Analysis (PHA) and Risk Analysis Chart (RAC) creation
Creation of DFMECA
Support Design Validation and Design Verification activities
Complaint Analysis, Prediction and Review
Reliability Assessment / Planning
What skills/attributes are a must have (Please be detailed as to number of years of experience)? Entry level 0-2 years. Engineering degree. Any experience supporting R&D, NPD, or Quality could be valuable
What skills/attributes are nice to have? Reliability Planning/Testing or Risk Management
What does the interview process look like?
How many rounds? 1
Video vs. phone? Video
How technical will the interviews be? Entry level position, generally less technical but may be some questions

Responsibilities may include the following and other duties may be assigned.
Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies - from design to implementation - while adhering to policies, using specialized knowledge and skills.

DIFFERENTIATING FACTORS
Autonomy: Entry-level individual contributor on a project or work team.
Works with close supervision.
Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities.
Innovation and Complexity: Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex.
Makes minor changes in systems and processes to solve problems.
Communication and Influence: Communicates primarily with internal contacts within immediate group.
Contacts others to gather, confirm and convey information.
Leadership and Talent Management: N / A - job at this level is focused on self-development.

Required Knowledge and Experience: Requires broad theoretical job knowledge typically obtained through advanced education.
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A), 0 years of experience required.