QUALITY ENGINEERING MANAGER

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.

JOB OVERVIEW

We are seeking an experienced Manager of Quality Engineering to lead the quality engineering function at our America manufacturing site. They will be responsible for building and executing an integrated quality strategy aligned with global regulatory requirements, corporate quality policies, and customer expectations, with a strong focus on tech transfer, risk management, control planning, end to end validation, and cross-functional collaboration.

SKILLS AND QUALIFICATION

• Bachelor’s or master’s degree in engineering, Life Sciences, or related technical field preferred.
• Minimum 10 years of quality experience in the medical device industry, with 5+ years in a managerial or leadership role preferred.
• Proven track record in managing and integrating internal and external customer requirements across engineering, assurance, and control in a regulated manufacturing environment.
• Proven track record of establishing and maintaining high performing team in a startup and fast-paced environment
• Proven track record of gating tech transfer project as a receiving site quality representative
• Expert knowledge of ISO 13485:2016, cGMP, FDA 21 CFR 820, 21 CFR part 11, ISO 14971:2019 & ICH Q9, ICH Q8, EN 62366-1:2015
• Strong expertise in tech transfer, end to end process validation, risk management, and QMS implementation.
• Excellent leadership, communication, and cross-functional collaboration skills.
• Proficiency in quality engineering tools (refer to ASQ Quality Engineering Body of Knowledge)
• ASQ CQE preferred.

• 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 between tech transfer receiving until satisfactory end to end process validation.
• Continuing and completing the efforts of building a quality engineering team at SHL Medical in North Charleston
• Develop the three quality engineering teams specializing in validation, automation, and injection molding respectively, and ensure synergies between the three teams
• Ensure department synergies and effective collaboration with key business partners including but not limited QA, Process development, mass production, Global QE, and Global tech transfer
• Ensures that departmental goals and objectives are aligned with SHL’s Quality Policies, Quality Engineering objectives and strategic plan, site objectives and strategic goal.
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• Ensure site specific requirements are accurately captured in technology transfer plan and executed effectively.

• Serve as the quality engineering leadership focal point for the site—responsible for ensuring product and process quality during new product introduction, tech transfer (new line introduction), and commercial production.
• Limited QA scope: support non-conformance management (NCR/CAPA) at a defined period when new lines are introduced to mass production.
• Promote a strong quality engineering culture across departments by coaching, mentoring, and empowering the quality team and cross-functional partners.
• Ensure timely and effective resolution of quality issues.
• Monitor and report on key performance indicators (KPIs) related to quality objectives, tech transfer effectiveness, and validation effectiveness.
• Performs other related duties as assigned.