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Quality Assurance Engineer SHL Medical - 4.0 North Charleston, SC Job Details Full-time 1 day ago Qualifications Regulatory inspections Bachelor's degree in mechanical engineering Statistics Molding (production process) Content creation for technical audiences Investigations regulatory compliance Production data analysis Quality control product testing Procedural guides ISO standards Quality control statistical data analysis Preventive action implementation Mechanical Engineering Technical writing experience within manufacturing Production deviation management Good documentation practices (GDP) Corrective and preventive actions (CAPA) Training material drafting Mid-level Manufacturing standard operating procedures Manufacturing process inspections Bachelor's degree in engineering Production validation processes Quality risk management Medical device manufacturing facility experience Quality assurance standard operating procedures Task prioritization Pharmaceutical company experience Technology transfer (scale-up process) Organizational skills Full Job Description 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 Assurance Engineer position would support, oversighting molding production process, 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 Team member representing Quality on product activities, providing quality insight on change control, validation of equipment and processes, and during product life cycle. Support the development and launch of new equipment for manufacturing processes. Review product performance using statistics tools to identify trends focusing on customer keeping a risk based thinking to prevent quality issues. Ensure Non-conformity Material is reviewed and disposed accordingly. Partner with Quality Control and manufacturing personnel to confirm failures, and support investigations. Stablish product inspections processes to assure sampling plans and procedures are align to customer's needs. Support test methods development and transfer activities, to ensure those are reproducible by receiving unit. 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. Technical writing skills for documenting progress, tracking closure of records, and creating training materials. Skills and Qualification 2-5 years of experience in the medical device, pharmaceutical or related regulated industry.

Knowledge of regulatory compliance:

GMP (good manufacturing practice), QSR (quality system regulations), and

ISO 13485

is preferred. Clear / logical thinking with strong organization and communication skills. Risk oriented based thinking. 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. Experience conducting complex investigations and implementing corrective actions. Bachelor's degree in Life Science, Mechanical Engineering or Engineering discipline. 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. For more information on SHL Medical, please visit: shl-medical.com