- 201351 - Quality Engineer
- $30 to $33.00 DOE
- 12 months
- Chipton-Ross is seeking a Quality Engineer for a contract opportunity in Eugene, OR.
You’ll provide Quality Engineering support to launch new fluorescent reagents supporting the life sciences market. You'll work with your internal business partners to ensure that products developed and launched from the site meet and exceed customer expectations and regulatory requirements.
Serve as a core team member of New Product Introduction teams, assuring design quality elements are maintained and fulfill ISO 13485 and applicable regulatory requirements (e.g. traceability matrix, design verification stages, process validation, quality control plan) Ensure that commercial use and custom products developed at the site have robust design history files, or have risk assessment files as appropriate. Work with internal teams including Procurement, Supplier Quality, R&D and Manufacturing to ensure that new products, sub-assemblies and raw materials have the necessary documentation and information required for a healthy product lifecycle. Support complaint handling for custom and commercial use SKUs as needed. Analyze processes related to new products, collaborating with R&D and Manufacturing to investigate trends, conduct root cause analysis and lead corrective actions, ensuring their effectiveness. Collect, analyze, and present Quality data to build and implement projects for improvement. Recommend product revisions, process changes, and/or testing procedures to assure that QMS standards are being attained. Build quality documents aligned to QMS standards and practices, revises quality documentation to better define, improve, or clarify practices, process and/or product quality. Participate as internal auditor for 9001 and 13485 standards, and participate in external audits. Other duties may be assigned, as required
Minimum 2-3 years of experience in a Quality Engineering position required – familiarity with and execution of principles within Certified Quality Engineer (ASQ CQE) Body of Knowledge preferred. Multi-year experience in the life sciences industry, with a knowledge of fluorescence imaging and flow cytometry highly preferred. Knowledge in standards including ISO 13485:2016 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes and ISO 9001:2015 – Quality Management System. Knowledge of Operations and manufacturing processes. Familiarity with enterprise software systems for document control and CAPA (e.g. Agile, TrackWise®) preferred. Makes good judgments and decisions and provides accurate advice on issues of work product quality nature and/or QMS compliance. Strong analytical and problem-solving skills with attention to details and the ability to find creative solutions that meet both QMS and business requirements. Demonstrated organizational and time management skills. Experienced in improving Quality Management Systems and promoting personal quality. Ability to balance complex and routine issues and multiple priorities. Able to motivate and positively influence peers, highly upbeat, and works well under stress
Accredited BS in Chemistry, Biology, or Engineering (Chemical, Biomedical, or Quality) or equivalent work experience in the Quality Engineering area pertaining to a scientific industry
Monday - Friday (8 a.m.- 4 p.m. - core hrs 9 -3)
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
6926 Rivers Ave
North Charleston, SC 29406
Phone: (843) 554-5800 x246 or (800) 927-9318 x246
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Employment will be contingent on candidate clearing pre-employment drug screen and background check.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.