Quality Engineer I
Artech LLC
North Haven, CT
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JOB DETAILS
SALARY
$45–$50 Per Hour
LOCATION
North Haven, CT
POSTED
21 days ago
Job ID: 24449
Location: North Haven Connecticut 06473
Duration: 12 Months
Pay Range: $45.00-$50.00 per Hr on W2
JOB DESCRIPTION
Work is performed at a minimum 4 days a week on-site in North Haven, CT,
This position is to support the design quality team for Sutures & Polymers in assessing and supporting design/process/manufacturing/supplier changes to ensure they meet our existing quality and reliability standards.
The direct team consists of 5 other engineers varying from Quality Engineer I to Principal Quality Engineer. Cross functional teams include manufacturing, R&D, Project Management, suppliers, etc.
The top five responsibilities are as follows:
Assess design/manufacturing/process/supplier changes
Review validation/verification documentation and provide feedback
Perform design failure modes effect analysis (DFMEA)
Complete risk assessments for proposed changes
Perform/support root cause analysis for product complaints
0-2 years of experience required with skills including but not limited to communication, critical thinking, collaboration, and attention to detail
Preferred qualifications:
Experience in the medical device industry or another highly regulated environment.
Working knowledge of quality systems, risk management, and design controls.
Strong written and verbal communication skills, including technical writing.
Experience supporting released medical device products.
Handson experience with DFMEA, risk management files, and design change quality reviews.
Knowledge of medical device lifecycle requirements, including design, manufacturing, distribution, and obsolescence.
Experience collaborating with crossfunctional teams to resolve quality issues and implement process improvements.
Familiarity with continuous improvement methodologies and root cause analysis techniques.
Work hours are approximately 9am-5pm EST
The interview process will be one Video Call (Client Teams) with behavioral based 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.
About the Company
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