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Form of workJob Description
Quality Engineer
Summary of Duties and Responsibilities:
Job Summary
Essential Duties and Responsibilities
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
Physical Demands
Qualifications
Education
Experience
Skills
Required
Beneficial
Notes:
Benefits:
About The Company:
#LI-GTT
- Contract Duration 6+ months
- Pay rate up to $42/hr
Summary of Duties and Responsibilities:
- The Quality Engineer 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 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.
Job 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.
- Design 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 with 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, and applying company policies and procedures to resolve a variety of issues.
- Normally receives general instructions on routine work, and detailed instructions on new projects or assignments.
Essential Duties and Responsibilities
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 coach others on BSH quality system requirements and standards to elevate the 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.
- Investigate and process Non-Conforming Events. (NCE).
- Prepares reports assessing the suitability and effectiveness of assigned areas of the quality system.
- Active participation in processes and meetings such as MRB, NCE, CAPA, and SCAR processes.
- 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
Experience
- 2-5 Years with Bachelor’s Degree
- 1-2 Years with a Bachelor’s Degree in Technical Field
- 0-2 Years with a Master’s Degree
Skills
Required
- Excellent computer skills including the 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 the 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
Beneficial
- 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 Engineer
Notes:
- SHIFT HOURS: 8-5
- Mostly onsite with the ability to work remotely 1 day/week
Benefits:
- Medical, Vision, and Dental Insurance Plans
- 401k Retirement Fund
About The Company:
- Our client is an innovative medical technology company whose purpose is to enable healthier lives everywhere, every day. While they Clients and develop groundbreaking products and services that benefit everyone, they are especially passionate about those that advance women’s health and well-being. This allows us to be a company that prospers, grows, and empowers women to experience healthier lives.
- What powers their growth across Breast & Skeletal Health, Diagnostic Solutions, and GYN Surgical Solutions is also what differentiates them: the exceptional and clinically proven ability of their products to detect, diagnose, and treat illnesses and other health conditions earlier and better.
- None of this would be possible without the talent, skills, and aspirations of their employees. Their proficiency and commitment to develop and share more robust, science-based certainty drives the company’s increasingly global presence, as well as a pipeline that responds to the unmet health and wellness needs of women, families, and communities.
#LI-GTT
