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
 

The Quality Engineer position supports / oversees process transfer, launch, scale up, manufacture, and post-market of SHL product to assure SHL quality high standards and compliance with applicable requirements, regulations and SOP’s.
Collaborates with regional and global counterparts to ensure consistency of critical processes. Effectively works with local, regional, and global employees to ensure regulatory compliance and SHL standards maintained across different sites.

Main Responsibilities

•    Represents Quality on product transfer activities, providing quality insight on change control, validation of equipment and processes, and during product life cycle.
•    Review product performance using statistics tools to identify trends focusing on customer and have  risk based thinking to prevent quality issues.
•    Support investigation of observed nonconformities during manufacturing process.
•    Establish product inspections processes to assure sampling plans and procedures are align to customer needs.
•    Support test methods development and transfer activities, to ensure those are reproducible by receiving unit.
•    Participates in risk management activities including review failure mode effects analysis (FMEA), hazard analysis, fault tree analysis (FTA) and/or risk or statistical analysis.
•    Promotes the use of statistics and a customer focus approach on product quality and control decisions.
•    Review validation protocols and reports to ensure compliance to validation governance documents and GDP requirements.
•    Drive Quality Improvement projects and CAPA activities to ensure prevent recurrence of observed or predicted issues and maintain a continuous improvement mentality. 
•    Supports creation of quality engineering procedures, systems and tools and applies them in a dynamic way to development and production projects.
•    Collaborate on the review and approval of device master records.
•    Performs other related duties as assigned.
•    Support Material Review Board and qualification process.
•    Support Change Request & review board.
•    Conduct internal audits and support customers or 3rd parties’ audits, on its area of expertise as SME.
•    Support test development activities.

Skills and Qualification

•    Bachelor’s degree in Life Science or Engineering discipline 
•    2+ years of experience in the medical device, pharmaceutical or biotechnology industry
•    Clear / logical thinking with strong organization and communication skills.
•    Ability to prioritize and to thrive in a cross-functional, inter-company and international environment.
•    Team player and self-starter, able to perform with low supervision.
•    A solution-oriented growth mindset coupled with decision-making skills.
•    Knowledge of regulatory compliance: GMP (good manufacturing practice), QSR (quality system regulations), and ISO 13485 is preferred.
•    SAP (Enterprise Resource Planning quality module will be an advantage).
•    Professional certification, such as Six Sigma, Quality Engineer preferable ISO 11608 experience is added advantage.
•    Professional certification, such as Six Sigma, Quality Engineer are an advantage.

We Offer

•    Competitive compensation package
•    Modern working environment with state-of-the-art facilities and technologies
•    Challenging assignments in a fast growing and innovative industry 
•    Position in a dynamic, international team of highly skilled professionals
•    Various opportunities for personal and professional development within a global organization

Please note that SHL is a drug free employer. This offer of employment is contingent upon your successful completion of various preemployment screenings, including, but not limited to, a drug test, employment verification, reference checks, and a criminal background check.
Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application including your CV, motivation letter, and all other relevant documents to our Talent Acquisition Department at RecruitUS@shl-group.com.

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