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Form of workJob Description
Job Title: Quality Engineer II
Job Location: Danbury, CT
Job Duration: 6 Months
Shift Hours: 8-5, Mostly onsite with the ability to work remote 1 day/week.
Pay Range : $20 - $42/hr. on W2.
Job Description:
Summary of Duties and Responsibilities:
Qualifications
Education
Job Location: Danbury, CT
Job Duration: 6 Months
Shift Hours: 8-5, Mostly onsite with the ability to work remote 1 day/week.
Pay Range : $20 - $42/hr. on W2.
Job Description:
Summary of Duties and 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.
- Has knowledge of commonly used concepts, practices, and procedures within a particular field.
- Relies on instructions and pre-established guidelines to perform the functions of the job.
- Works under immediate supervision.
- Primary job functions do not typically require exercising independent judgment. Typically reports to a supervisor or manager.
- The incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs.
- Model all quality values and coaches others on BSH quality system requirements and standards to elevate team's ability to produce high-quality products and implement best practices that emphasize defect prevention, reduction in variation and waste and provide for continuous improvement.
- 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. Provides training as required.
- 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.
- Investigates and processes Non-Conforming Events. (NCE).
- Prepares reports assessing the suitability and effectiveness of assigned areas of the quality system.
- Active participate in processes and meetings such as MRB, NCE, CAPA and SCAR process.
- 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.
- Active participant in facility and supplier audits and Notified Body and FDA inspections.
- Physical Demands
- The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Sit; use hands to finger, handle or feel objects, tools, or controls.
Qualifications
Education
- Bachelor s Degree (Technical Field Preferred), May have master s degree
- 2-5 Years with bachelor s degree
- 1-2 Years with bachelor s degree in Technical Field
- 0-2 Years with master s degree
- Excellent computer skills including ability to use word processing, spreadsheet programs and databases
- Excellent ability to read, analyze and interpret professional journals, technical procedures and government regulations.
- Excellent technical writing skills with ability to write quality assurance reports and details procedures
- Good presentation skills
- Good interpersonal skills to interact with all levels of the company, sometimes in an adversary role
- Knowledge of GMP and GDP Principles
- Working knowledge of medical device Quality System Regulations (21CFR820), ISO 13485 and MDD requirements
- Knowledge of microbiology, molecular biology, biochemistry, chemistry and/or related disciplines
- Understanding of nucleic acid amplification and detection technologies
- Understanding of Scientific Method and statistical analysis
- Knowledge of Oracle and Agile
- Experience in an FDA regulated industry
- Certified Quality EngineerShift Hours: 8-5
