What are the responsibilities and job description for the Quality Engineer position at Raland Compliance Partners, LLC?
Client Summary: Our client is a premier plastic packaging, dispensing, and medical device provider serving the Medical, Pharmaceutical, Consumer Healthcare, Personal and Home Care, Food and Beverage, and other niche market segments.
Job Responsibilities:
Develop and improve processes by studying product manufacturing methods supporting Quality improvement objectives
Job Duties:
Skills and Knowledge:
Job Responsibilities:
Develop and improve processes by studying product manufacturing methods supporting Quality improvement objectives
Job Duties:
- Evaluate manufacturing processes by applying knowledge of product design, fabrication, assembly, tooling, and materials; conferring with equipment vendors
- Develop/improve manufacturing processes by studying product requirements, researching, designing, modifying, and testing manufacturing methods and equipment
- Improves manufacturing efficiency by analyzing and planning workflow, space requirements, and equipment layout.
- Support product and process quality by designing/improving testing methods
- Supporting product and process Validation protocols (IQ/OQ/PQ)
- Provides quality-related manufacturing decision-making information by calculating production, labor, and material costs
- Prepares product and process reports by collecting, analyzing, and summarizing information and trends.
- Provides manufacturing engineering information by answering questions and requests.
- Develop/improve SOP's and Work Instructions per Client standards
- Support authoring training content
Skills and Knowledge:
- A minimum of 3 years of relevant experience as a Manufacturing / Quality Engineer in the medical device industry with plastic molding experience
- Demonstrated knowledge of regulations and standards that apply to the medical device industry; ISO 13485 and 21CFR Part 820
- In-depth understanding of the application of quality systems to the medical device industry
- Familiarity with Lean, 5s practices preferred
- Excellent communication skills at all levels both written and verbal.
- Ability to perform multiple tasks and prioritize workload.
- Effective analytical, technical, and problem-solving skills.
- Self-motivated /directed