Quality Engineering Manager

Overview

Location : Charleston, South Carolina, US

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

Responsibilities

• Lead and manage US site quality engineering team to ensure consistent execution of the Quality Management System (QMS) in compliance with ISO 13485 and related global regulations, from tech transfer receiving through end-to-end process validation.
• Continue building a quality engineering team at SHL Medical in North Charleston and develop three linked teams specializing in validation, automation, and injection molding, ensuring synergies among them.
• Establish and maintain effective collaboration with key business partners including QA, Process Development, Mass Production, Global QE, and Global Tech Transfer.
• Align departmental goals with SHL's Quality Policies, Quality Engineering objectives, strategic plan, and site objectives.
• Capture site-specific requirements in technology transfer plans and execute them effectively.
• Serve as the quality engineering leadership focal point for the site, ensuring product and process quality during new product introductions, tech transfer, and commercial production.
• Support non-conformance management (NCR / CAPA) at defined periods when new lines are introduced to mass production.
• Foster a strong quality engineering culture through coaching, mentoring, and empowering the quality team and cross-functional partners.
• Ensure timely and effective resolution of quality issues and monitor key performance indicators (KPIs) related to quality objectives, tech transfer effectiveness, and validation effectiveness.
• Perform other related duties as assigned.

Qualifications

We Offer

Please note that SHL is a drug-free employer. This offer of employment is contingent upon successful completion of pre-employment screenings, including drug test, employment verification, reference checks, and a criminal background check.

For more information on SHL Medical, please visit : shl-medical.com

Details

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