SHL Medical is seeking a Quality Engineering Manager to lead the quality engineering function at their America manufacturing site, ensuring compliance with global regulatory requirements, corporate quality policies, and customer expectations.
Requirements
- 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.
- Proficiency in quality engineering tools (refer to ASQ Quality Engineering Body of Knowledge)
- 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
- ASQ CQE preferred
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 between tech transfer receiving until satisfactory end to end process validation.
- 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
- 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.
- Monitor and report on key performance indicators (KPIs) related to quality objectives, tech transfer effectiveness, and validation effectiveness.
- 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.
Other
- 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.
- Excellent leadership, communication, and cross-functional collaboration skills.
- Position requires passing a drug test, employment verification, reference checks, and a criminal background check.
- Travel requirements not specified
