Position Summary
Apply quality engineering sciences and principles to all phases of product lifecycle: planning, development, qualification, manufacturing, and continuous improvement.
Essential Duties and Responsibilities
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Provide necessary definition, development, and deployment of the company product quality assurance strategy, addressing all phases of product development, utilizing APQP (Advance Product Quality Planning) principles, including IQ/OQ/PQ validation process.
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Work directly with the customer to identify problems, relay containment to customer and form a corrective action team. Identify root cause and undertake corrective action policy. Write corrective action and report back to the customer.
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Manage and organize comERP System sets of data to aid in the identification and scope of corrective action activities.
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Ensure corrective actions are implemented on the floor and present corrective action to the customer.
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Create validation protocols and lead validation activities. Prepare and review validation reports and verify they are ready to submit to the customer.
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Apply advanced statistical analysis tools to determine if processes are in control and process capabilities are acceptable for existing and developing products.
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Solve comERP System problems using CAPA system and various problem-solving tools.
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Be the lead authority on the production floor related to product quality and acceptance requirements. Effectively disseminate these requirements to all affected employees’ plant wide.
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Communicate significant issues or developments identified during quality assurance activities and provide recommended process improvements to management and others.
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Initiate and/or lead continual improvement projects to successful completion.
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Manage the planning and execution of product testing efforts, including all associated resources to meet committed delivery dates, in support of new product launch.
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Maintain product consistency through all phases of manufacturing, to include the design reviews, build phases and all quality checkpoints and testing.
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Develop and implement standards and methods for inspection, testing and evaluation of materials, products, and processes. Will also compile and write manufacturing and inspection instructions/protocols to support this activity.
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Design and Conduct measurement system analysis to verify methods are capable.
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Devise sampling procedures, design and develop forms and instructions for recording, evaluating, and reporting quality and reliability data.
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Develop/implement programs to evaluate analytical testing, equipment, facilities, manufacturing processes, precision measurements, accuracy measurements and performance testing.
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Direct quality department employees on processes for measuring, testing and tabulating data.
- Work independently and in a team environment to support the daily function of the manufacturing operation.
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Work with cross functional teams on continuous improvement projects and new program launches to ensure manufacturing process and products are optimized and cost effective.
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Simultaneously fulfill responsibilities on multiple programs with multiple customers.
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Conduct internal quality management system audits.
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Update quality plans, work instructions, procedures and other QMS documentation as needed.
This job description indicates the general nature and level of work, duties and responsibilities expected of the incumbent. The incumbent may be asked to perform other duties as required. The job description may be changed if needed as determined by the Company.
Required Competencies, Skills, and Experience
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Experience in Plastic Injection Molding
- Experience in Medical Device manufacturing or other highly regulated products
- Strong analytical skills
- Knowledge of Project Management concepts and skills
- Desire for achieving excellence in customer satisfaction, process and product quality and reliability.
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Strong detail-oriented written and verbal communication skills, including customer interactions.
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Ability to manage difficult or emotional customer situations; Respond promptly to customer needs; Solicit customer feedback to improve service; Respond to requests for service and assistance; Meet commitments.
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Ability to respond well to questions, demonstrate group presentation skills and actively participate in meetings.
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Proficient in Geometric Dimensioning & Tolerancing GD&T ASME Y14.5, and specification reading.
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Proficient knowledge of and practical experience with process validation concepts, phases (IQ, OQ, PQ) and applications, including protocol development and summary reporting.
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Working knowledge of ISO-13485 and FDA cGMP
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Proficient in Design of Experiments (DOE)
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Proficient in process failure modes and effects analysis (PFMEA)
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Strong knowledge of and practical experience using problem solving & root cause analysis tools (e.g., 8D, 5Why, fishbone, cause, and effect, etc.)
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Proficient in measurement system analysis (GR&R)
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Application of time management tools
- Advanced knowledge of industry statistics including proficient use of Mini-Tab or similar statistics analysis software.
Preferred Skills
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ASQ certification, preferred.
Education and Job Experience Requirements
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BS Degree in Engineering or equivalent experience
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ASQ certification, preferred.
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Minimum 5 years of work experience
Work Environment and Physical Demands
- Regularly required to sit and use hands.
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Occasionally need to lift and/or move up to 10 pounds, with a potentialof up to 25 pounds.
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Physical hazards from moving equipment and machine parts
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Sedentary, office environment; frequent exposure to manufacturing plant floor requiring the use of personal protective equipment (ear plugs, safety glasses, etc.) and following good manufacturing practices.
The work environment and physical demands detailed above are representative of those encountered while performing the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job.
Disclaimer
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time as needed.