Quality Engineer Manufacturing - Entry level

TITLE: Quality Engineer II

LOCATION: Danbury CT (SHIFT HOURS: 8-5 / Mostly onsite with the ability to work remote 1 day/week)

DURATION: 6 months + extension/or conversion to PERM

Interview Process: 1st Round virtual, 2nd round ONSITE

Responsibilities:

- Performs inspections and sets quality assurance testing models for analysis of raw materials, materials in process, and finished products.

- Requires a bachelor's degree and 0-2 years of experience in the field or in a related area.

- Relies on instructions and pre-established guidelines to perform the functions of the job/Works under immediate supervision.

SUMMARY

Designs, implements and maintains quality assurance protocols and methods for processing materials into partially finished or finished products. Responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external safety, quality and regulatory standards requirements for worldwide distribution. Designs methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products. Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary. May assure compliance to in-house and/or external specifications and standards (i.e. GLP, GMP, ISO, Six Sigma).

Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action. Builds productive internal/external working relationships.

Developing professional expertise, applies company policies and procedures to resolve a variety of issues. Normally receives general instructions on routine work, detailed instructions on new projects or assignments.

Responsibilities

• Provide Quality Engineering support to Operations, Engineering and R&D in the design and manufacture of medical devices to ensure robust product builds and the production of high-quality products and manufacturing practices.

• Responsible for ensuring that the products produced meet applicable regulatory and quality standards and customer expectations.

• Develops and implements procedures, inspection procedures and test methods in compliance with QMS, Medical Device Quality System Regulation and Medical Device Directive requirements.

• Acts with urgency to Identify and provide timely resolution to quality issues. Perform risk assessments and update risk management documentation as required.

• Perform customer complaint investigations, root cause investigations, root cause analysis, problem solving and corrective actions.

• Reviews technical publications, articles and abstracts to stay abreast of technical developments in the industry.

• Prepares reports assessing the suitability and effectiveness of assigned areas of the quality system.

• Review and approve routine to moderately complex ECO’s product related change orders, engineering studies, sustaining engineering products, specifications, drawings, manufacturing procedures, design process verification and validation documentation.

Education

• Bachelor’s Degree (Technical Field Preferred), May have Master’s Degree

Experience

• 2-5 Years with Bachelor’s Degree

• 1-2 Years with Bachelor’s Degree in Technical Field

• 0-2 Years with Master’s Degree

Skills

• Required

o Excellent computer skills including ability to use word processing, spreadsheet programs and databases

o Excellent ability to read, analyze and interpret professional journals, technical procedures and government regulations.

o Excellent technical writing skills with ability to write quality assurance reports and details procedures

o Good presentation skills

o Good interpersonal skills to interact with all levels of the company, sometimes in an adversary role

o Knowledge of GMP and GDP Principles

Beneficial

o Working knowledge of medical device Quality System Regulations (21CFR820), ISO 13485 and MDD requirements

o Knowledge of microbiology, molecular biology, biochemistry, chemistry and/or related disciplines

o Understanding of nucleic acid amplification and detection technologies

o Understanding of Scientific Method and statistical analysis

o Knowledge of Oracle and Agile

o Experience in an FDA regulated industry

o CertifiedQuality Engineer