Quality Specialist

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

SHL is seeking a meticulous and detail-oriented Quality Specialist to play a critical role in ensuring the quality and compliance of our products. This individual will be responsible for the thorough review of batch Device History Records (DHRs), As well as, the life cicle management of Inspection Plans to assure keeping those are align with custome expectations and high standard. Additionally, the Quality Specialist will actively participate in other quality management system (QMS) activities, contributing to the overall effectiveness.

Main Responsibilities

• Perform detailed reviews of completed batch Device History Records (DHRs) in a timely manner, ensuring all entries are accurate, complete, and compliant with Good Manufacturing Practices (GMP), internal procedures, and applicable regulations (e.g., 21 CFR Part 820, ISO 13485).
• Initiate and follow up on investigations related to DHR discrepancies, ensuring timely and effective resolution.
• Collaborate with manufacturing, engineering, and other departments to clarify information and ensure DHR accuracy.
• Review product performance using statistics tools to identify trends focusing on customer keeping a risk based thinking to prevent quality issues.
• Ensure inspection plans accurately reflect product specifications, quality requirements, and testing procedures.
• Revise and update inspection plans in SAP QM based on process changes, product updates, and quality events.
• Support investigation of observed nonconformities during manufacturing process.
• 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.
  
  

Skills And Qualification

• Bachelor's degree in a scientific or technical field (e.g., Biology, Chemistry, Engineering) or equivalent experience in a regulated industry.
• Professional certification, such as Six Sigma, Quality Engineer are an advantage.
• 3 years of experience in a quality assurance role within a regulated environment (e.g., medical device, pharmaceutical, biotechnology).
• Knowledge of regulatory compliance: GMP (good manufacturing practice), QSR (quality system regulations), and ISO 13485 is preferred.
• Excellent analytical and problem-solving abilities.
• Effective written and verbal communication skills.
• Knowledge of statistical process control (SPC).
• 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.
  
  

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