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Quality Manager / ISO MGMT Rep


Position Description
Position Title: Quality Manager / ISO MGMT Rep
Department: Quality
Reports To: Executive Vice President
Position
Summary:
This role will serve as the quality management representative and the primary project manager/leader maintaining the implementation and compliance of our quality management system to ISO 13485 and 9001 device manufacturing standards. Carries out a responsive quality effort to process profitable customer orders and help Servtech Plastics exceed customers' expectations. Works on operations, improving profitability, efficiency, and productivity. interfaces with Sales, Engineering, Production and other business units.

Primary Responsibilities:
Provides Leadership:
1. Provides coordination of quality procedures, instructions, specifications, and standards to ensure conformance to ISO standards and customer specifications/requirements.
2. Leads QMS steering team.
3. Assists in resolution of equipment/technical/personnel problems.
4. Assists in guiding the activities of Servtech Plastics.

Provides Technical Support Services:
1. Oversee and maintain quality planning, non-conforming material, document and data control and corrective action systems within Servtech Plastics.
2. Consult with management in resolution of quality problems and provide feedback in preparation of technical appraisals and corrective action plans. Lead cross-functional teams in conducting Root Cause Analysis (RCA) and Corrective and Preventative Action (CAPA) efforts.
3. Specifies and maintains necessary QC equipment to ensure conformance to customer specifications.
4. Oversees and performs (external and internal) auditing functions.
5. Regularly analyzes services provided for customers to develop new ways to better satisfy customer needs (new/different equipment, alternative work methods, improved quality/service, etc.).
6. Works with customers in determining feasibility of new/difficult applications; assists in setting up complex/difficult jobs.
7. Supports the improvement of shop floor work flow and existing injection molding processes; specification, justification, and acquisition of new equipment, rework/improvement of existing equipment.

Provides Administrative Support:
1. Provides periodic quality summary reports for Management Review.
2. Educates/trains/coaches employees on quality and continuous improvement concepts.
3. Designs, organizes, and completes employee training programs.
4. Oversees technical writing projects concerning quality and production procedures.
5. Manages external consultant resources and project plans between our US and China locations.
6. Create and document standard operating procedures (SOP) to support operations.
7. Develop and maintain an internal audit schedule, reports, corrective actions, and review in accordance with Quality Policy and continuous improvement needs.
8. Completes other tasks as assigned by supervisor.

Hiring Qualifications:
Four year technical degree
Five to ten years industrial/supervisory experience with five years quality related experience
Must have ISO 9001, ISO 13485 and/or FDA experience
Must have knowledge of GMP 21 and CFR 211 and FDA Regulatory submission
Strong background in statistics, quality inspection methods, inspection equipment and AQL
Strong organizational, interpersonal, leadership, written communication and computer skills
Good understanding of injection molding equipment and methods and dimensional tolerancing desired
Applicants must be authorized to work in the U.S

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