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Quality System Manager

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EmbedTek LLC

Posted on 06/12/2019

Location

Waukesha, Wisconsin, United States

Description

EmbedTek is a Waukesha, Wisconsin based firm that designs and manufactures embedded systems for OEMs. These systems include deeply embedded computer systems, liquid crystal display (LCD) based products, industrial and factory floor computers, industrial I/O & power control and board level component subsystems. EmbedTek provides creative solutions that help our customers to be market leaders in their specific field. We become an extension of our customer’s R&D department and develop a thorough understanding of short and long term needs. This allows our customers to produce products which will take the lead and stay ahead of competition.

The Quality department is critical to the company’s success in providing quality products to our customers in a timely fashion. The Quality System Manager position helps ensure that our products meet the requirements of our customers and that we operate efficiently and effectively in compliance with both internal and external standards/regulations. This position provides an opportunity to participate in the early stages of a growing business and to enhance a customer focused manufacturing environment in support of the company’s strategic growth.

Major Duties & Responsibilities

  • Manage the use and enhancements of the Quality Management System (QMS); author, revise, review/approve, and publish controlled QMS documentation
  • Maintain QMS certifications and required registrations with all applicable regulatory authorities
  • Ensure ongoing compliance to all applicable ISO/regulatory requirements through, among other means, process documentation, communication/training, and internal audits
  • Manage customer complaint/feedback records; support the associated root cause investigations and the determination of appropriate corrective/preventative actions; evaluate the need for advisory notes/recalls
  • Represent the company in all customer and regulatory audits
  • Plan and conduct management reviews
  • Lead continuous improvement initiatives across all departments in support of strategic objectives; ensure effective risk management is implemented throughout the QMS
  • Support all departments by providing interpretation and guidance related to the QMS and ISO/regulatory requirements
  • Serve as a point of contact for customers related to product and process compliance with both customer and ISO/regulatory requirements
  • Support new product development and product changes by participating in Engineering reviews, completing Engineering Change Request tasks, and guiding verification/validation activities

Minimum Skills & Abilities

To perform the Quality System Manager job successfully, an individual must be able to perform each essential duty satisfactorily with a customer service perspective. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Working knowledge of ISO QMS standards, including ISO 13485, and US FDA 21 CFR 820
  • Ability to manage customer complaints, corrective/preventive actions, advisory notes/recalls, verification/validation activities, and continuous improvement initiatives
  • Ability to collaboratively determine, document, implement, and improve lean processes that add value to the company while ensuring compliance to customer and regulatory requirements
  • Self-motivated and self-disciplined to accomplish assigned responsibilities while working independently
  • Ability to determine and manage priorities, to remain organized and focused on the details, and to remain in compliance with internal procedures, especially when working with short timelines and critical due dates
  • Proficient in Microsoft Office applications, including Excel and Word

Minimum Education & Experience

  • Bachelor’s degree in a technical or engineering discipline
  • Minimum of 3-5 years of experience working in a Quality role
  • Experience conducting audits and/or hosting both customer and regulatory audits
  • Experience associated with medical device manufacturing is preferred
  • ASQ, AAMI, or other quality certifications are preferred


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