- 196225 - Quality Engineer III - Quality Assurance
- $150 to $155.00 DOE
- 3 mos
- Chipton-Ross is seedking a Quality Engineer III - Quality Assurance for an opening in Auburn, AL.
This contingent position is for a self-driven and resourceful Quality Engineer with up-to-date knowledge, and demonstrated experience to lead Quality Control activities and to manage Technical Quality processes to ensure compliance with ISO 9001:2015 and 21 CFR 820 for our site in Auburn, AL site.
Assist Quality Assurance Manager in establishing, implementing, maintaining, and improving the site quality management system. Coordinates resources to ensure prompt, comprehensive incoming and in-process in support of product release, handling of OOS and follow up to ensure continuity of service. Ensure timely release of products, handling of Nonconforming products and planned deviations related to production, follow up on NCR (Non Conformance Report) and CAPA. Drive standardization and optimization of technical processes e.g. DMR, Control Plans, risk management, calibration metrology, etc. Plan, develop and approve documentation for process, test method, and software validation. Provide support with data analysis, statistical rationale and sample plans. Lead investigations and root cause analysis for complex problems. Management of the Calibration function for Quality-related processes and manages to ensure the right prioritization is performed to support operations. Drive projects and improvements/standardization across the network to improve Quality service levels, reduce costs, and align with strategic objectives. Help sites prepare for, and actively support, external audits (customer & regulatory) ensuring corrective/preventative actions are put in place to address identified non-conformances. Lead to ensure a high performing, efficient team with focus on job satisfaction and people development. Coach and support team members through their technical and professional development. Provides leadership and coaching to the Operations Quality team. Works closely with Operations to ensure that all aspects of the QMS is understood, implemented and maintained. Supports Corrective and Preventive Action System. Works with various departments to assure corrective and preventative actions are properly implemented. Coordinates and participates in any internal, external or customer audits as the need arises. Executes on QA/QC priorities and key objectives to reduce the cost of poor quality while improving the compliance to regulations and the site Quality System. Manages factory Quality Metrics. Other duties may be assigned, as the need arises.
Minimum of 5 years of professional experience in Quality Engineering, Operations Quality or Quality Manager role. Minimum of 3-year experience as people’s manager. Strong problem solving and analytical skills and developed understanding of risk management. Must be able to influence & negotiate with people & resolve issues. Ability to make rational, objective and appropriate decisions relating to company & department requirements. Ability to identify customer needs and issues. Develop realistic solutions to meet customer needs and solve problems. Communicate recommendation and decisions across the organization. Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies, in-depth understanding of products and processes. Experience at effectively communicating complaints, risks, production, process controls, Corrective and Preventive Action (CAPA) and improvements. Demonstrated ability to lead in a fast-paced technical environment, absorb technical information, review technical information and make technical decisions. Experience working in a GMP environment such as Medical Device industry or plastic consumables. Strong communication and writing skills. Excellent communication and presentation skills. Proficient with Microsoft tools; Word, Excel, Power Point. Working experience with cGMP requirements (21 CFR 820) and MDR. Ability to analyze and process data and draw the appropriate conclusions. Experience prioritizing conflicting demands. Excellent interpersonal, organizational, and influencing skills. Ability to analyze and process data, and draw the appropriate conclusions. Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems.
ASQ Certified Quality Engineer is preferred or similar certification. Working experience with TrackWise, SAP, and Documentum or similar IT systems. Six Sigma and Lean Manufacturing experience. Experience with Lean or Six Sigma improvement systems. Experience in high volume plastics/molding industry.
Accredited Bachelor's degree (or higher) in an engineering, science, operations or related field.
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x251 or (800) 927-9318 x251
To ensure compliance with President Biden’s September 9, 2021 executive order, the client is implementing a new requirement for U.S.-based employees to either show proof of being fully vaccinated from COVID-19, or have an approved reasonable accommodation (based on a disability/medical condition or sincerely held religious belief) exempting them from the requirement, by December 8, 2021 (timing may vary in some states). Individuals who are unable to meet COVID-19 requirements due to a disability/medical condition or sincerely held religious belief may apply for a reasonable accommodation during the post-offer process. Individuals with approved accommodations will be subject to frequent COVID-19 testing.
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.