Product Quality Lead

**About SHL Medical**

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 Product Quality Lead will ensure excellent communication with and support to internal and external customers. The Product Quality Lead will ensure the delivery of high-quality product which meet the regulatory requirements and customer expectations. The Product Quality Lead will be responsible for managing quality risk, complaints, change controls, deviations, CAPA, internal audits, product quality reviews, data training, local product release, and oversight of GDP and GMP requirements for local manufacturing, warehousing and distribution.

**Main Responsibilities**
- Lead Quality Operations activities at a new manufacturing site
- Lead compliance assurance and monitoring of manufacturing related activities on site,
- Lead product and processes quality data analysis and trends, identifies improvement activities
- Support Process Validations and Qualifications (molding, assembly, testing)
- Prepares Inspection Plans and applies appropriate AQL/RQL strategies
- Prepare and perform Quality review of batch release documents
- Provide comprehensive quality assurance oversight for all activities in Zug site
- Present quality data, trends and conclusions to customers, suppliers and management teams
- Lead nonconformities and failure investigation whenever components, assemblies or product specifications are not met
- Act as Quality approver for change controls, deviations and Corrective and Preventive Actions (CAPAs), and support Quality Control (QC) related activities
- Complete the evaluation and detailed investigation on the observed nonconformities
- Employ advanced analytical and statistical techniques and methodologies when leading RCAs and CAPAs or investigations
- Support external quality inspections and execute the strategy for internal site audits
- Lead continuous improvement initiatives aimed at enhancing quality, efficiency, and effectiveness

**Minimum Requirements**
- Minimum 10+ years of experience in Medical Device or Pharma industry in Quality disciplines
- Expert knowledge in medical devices/combination products compliance (ISO 13485, QSR, MDR)
- Expert knowledge in statistics (Trends, simulations, capabilities analysis)
- Certified Internal Auditor
- CQE certification, Black Belt in Lean Manufacturing is a plus
- Demonstrated problem solving and critical thinking
- Clear / logical thinking with strong organization and communication skills.
- CQT (certified quality technician), CQE (certified quality engineer) is a plus.
- Six sigma green belt or black belt is a plus.
- Minitab skills are a plus.
- Language: Fluent in English

**Preferred Qualifications**
- Master’s degree in engineering or life science
- Language: Fluent in German

**We Offer**
- Challenging assignments in a fast-growing and innovative industry.
- A multicultural team and modern working environment with state-of-the-art facilities and technologies.
- A place where we take pride in the inclusive and collaborative environment we have built - one where a true sense of belonging fosters meaningful exchange and shared growth.
- Various opportunities for personal and professional development within a global organization.
- Flexible hours and hybrid working policy.