Description

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

• 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.
• Develops and implements risk management tools (e.g., pFMEA, etc.) to incorporate into control planning strategies.
• Manages the planning and execution of quality assurance strategies as well as product testing efforts, including all associated resources to meet committed delivery dates, in support of new product launch
• Implements control plan elements to maintain product consistency through all phases of manufacturing.
• Develops and implements 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
• Develops sampling procedures, designs and develops forms and instructions for recording, evaluating and reporting quality data.
• Develops/implements programs to evaluate analytical testing, equipment, facilities, manufacturing processes, measurement systems and performance testing.
• May direct quality department employees on processes for measuring, testing and tabulating data
• Will work independently and in a team environment to support the daily function of the manufacturing operation
• Will work with cross functional teams on continuous improvement projects and new program launches to ensure manufacturing process and products are optimized and cost effective
• Problem solving using formal CAPA tools.
• Simultaneously fulfil responsibilities on multiple programs with multiple customers

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.

Qualifications

Required Competencies, Skills, and Experience

• Experience in Plastic Injection Molding desired.
• Experience in medical or pharma manufacturing desired.
• Strong analytical skills
• Knowledge of Project Management concepts and skills
• Desire for achieving excellence in customer satisfaction, process and product quality and reliability
• Strong detail-oriented written and verbal communication skills, including customer interactions.
• Basicknowledge and experience with process validation concepts, phases (IQ, OQ, PQ) and applications, including protocol development and summary reporting.
• Proficient in Design of Experiments (DOE) desired.
• Proficient in process failure modes and effects analysis (pFMEA) desired.
• Strong knowledge of and practical experience using problem solving & root cause analysis tools (e.g., 8D, 5-Why, fishbone, cause and effect, etc.)
• Proficient in measurement system analysis (MSA/GR&R) desired.
• Proficient in Geometric Dimensioning & Tolerancing GD&T ASME Y14.5, and specification reading, desired.
• Working knowledge of ISO-13485 and FDA cGMP.
• Application of time management tools.
• Advanced knowledge of industry statistics including proficient use of Minitab or similar statistics analysis software.

Education and Job Experience Requirements

• Minimum of a four-year Engineering / Technical Degree or equivalent experience (i.e., 2 to 4 years).
• Minimum of five years (3) of experience in a similar role.
• Completion of Paulson Training, QMS and cGMP practices are required.
• ASQ certification, preferred.

Work Environment and Physical Demands

• Regularly required to sit and use hands
• Occasionally need to lift and/or move up to 10 pounds, with a potentialof up to 25 pounds.
• Physical hazards from moving equipment and machine parts
• Sedentary, office environment; frequent exposure to manufacturing plant floor requiring the use of personal protective equipment (e.g., 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.