JOB PURPOSE

This position is accountable for managing, planning, organizing, directing, and controlling a Quality Assurance Program which includes quality control, quality engineering, regulatory compliance and product safety functions to ensure customer requirements are satisfied. Serve as the site advisor on regulatory compliance; assists with tracking submissions (FDA and international); manages required MDR/vigilance reporting; ensures regulatory requirements are integrated into the plant's quality system documentation and complies with all FDA QSR's. Facilitate problem-solving efforts (corrective action) utilizing appropriate tools such as error-proofing, 5S, FMEAs, cause-and-effect diagrams, 5-Whys, flowcharting, statistical methods. Provide training to individuals that may lead problem-solving or improvement activities.

ESSENTIAL DUTIES

Manage, plan, direct and control the company's quality assurance system which assures high product quality and reliability to meet the quality parameters, specifications and characteristics of design, application and function in accordance with applicable industry and regulatory standards. Plan and develop plant-specific systems to determine to what extent product properties are designed and built into a product to meet the design, manufacturing, and customer requirements through various techniques including quality planning, inspection, audits, verifications, validations, evaluations, tooling and equipment. Establish and maintain control procedures and standards for the control and assurance of product quality, reliability, and testing conformance to engineering and applicable industry standards. Manage, plan, direct and control the resources of the quality assurance organization to optimize the effective utilization of those resources within budgetary requirements, costs and quality standards. Identify, document and assure that all quality related matters are communicated properly including problems and potential problems on a timely basis. Direct work groups of technical employees from various departments as required to solve critical quality problems. Establish priorities, determine and obtain resources and conduct follow-up action as required to assure resolution of quality issues. Direct the problem analysis function for manufacturing and field service related problems. Provide technical assistance for problem analysis relating to new product design problems. Plan, direct, and control a problem prevention system for machines, tools, dies, fixtures, inspection equipment and test facilities to assure product compliance to applicable industry specifications and standards. Responsible for the identification and control of discrepant materials, parts and products and the ultimate decisions of product quality, reliability and suitability for shipment to customers. Represent the company in matters pertaining to quality and product reliability problems through sales coordinated key customer visits. Also plan and direct off-site vendor audits to insure conformance to applicable industry standards. Serves as location leader/management representative for the plant's certifications (e.g., ISO9001, ISO13485, FSSC 22000, etc.) Participate in new product development teams representing quality system requirements, national standards, and International Quality system standards such as

ISO-9001, IEC

Standards, NEMA, ANSII, and ASTM as assigned. In that capacity, approve new product development authorizations as the Quality Assurance team representative. Issue, coordinate and control production and shipment holds as required to control the flow of defective items or finished products. Direct work groups of both technical and non-technical employees from various departments as required to resolve all production and shipment holds. Conduct product and internal quality system audits in accordance internal requirements. In addition, direct product audit teams and coordinate follow-up activity as assigned. Participate in vendor audits as assigned.

QUALIFICATIONS

(Education/Experience/Knowledge, Skills & Abilities)

Required:

Bachelor's Degree in science or engineering discipline. Other degrees are acceptable with appropriate quality assurance experience. Knowledge of product, application, and quality assurance concepts usually gained through 5 to 7 years combined experience in Engineering, Manufacturing, and/or Quality Assurance functions. General knowledge of governmental regulatory compliance, preferably FDA requirements for medical devices including product submissions (510k) Desired attainment of national/internationally recognized certification in the areas of quality engineering, auditing and management (e.g., American Society for Quality (ASQ)

CQE, CQA, CMQ/OE

) Knowledge and experience with contemporary improvement tools such as Lean concepts, Error Proofing, 5S, Capability Analysis, APQP, SPC, FMEAs, DoE, etc. Must be a self-starter with the ability to work alone, or in a team environment with limited supervision. Candidate should have excellent verbal and written communication skills and must be able to function in a multi-tasking capacity. Excellent computer and data analysis skills. Candidate must be proficient in Microsoft Word, Excel, PowerPoint, and Outlook.

Preferred:

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