Quality Engineer
Quality Engineer
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Quality Engineer
Location: Charleston South Carolina US
Reporting to: Quality Manager
SHL Medical is a world-leading provider in the design development and manufacturing of advanced self-injection devices. With a global team of 6000 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 would support oversighting 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 SOPs.
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 transfer 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.
- Support investigation of observed nonconformities during manufacturing process.
- Support Non-conformity Material Review Board.
- Stablish product inspections processes to assure sampling plans and procedures are align to customers 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.
Skills and Qualification
- Bachelors degree in Life Science Mechanical Engineering or Engineering discipline
- Professional certification such as Six Sigma Quality Engineer are an advantage.
- 2 years of experience in the medical device pharmaceutical or biotechnology 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.
Preferred:
- SAP (Enterprise Ressource Planning quality module will be an advantage).
- ISO 11608 and 14971 experience is added advantage.
- Able to travel internationally (up to 10%).
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:
Employment Type
Full Time
