Bai Angelo e figlio SA seeks a Quality Engineer in Bettlach to uphold ISO 13485 standards, lead CAPA initiatives, and support manufacturing quality within a regulated medical device environment.
This position sits within the quality team at the Jabil Bettlach facility and reports directly to the Supervisor of Quality Engineering. The role focuses on ensuring that manufactured products adhere to strict regulatory and quality benchmarks while driving continuous improvement through structured methodologies.
Responsibilities
Partner with production and engineering departments to guarantee that outputs satisfy all quality and regulatory mandates.
Develop quality control documentation and suggest appropriate tools and techniques for monitoring standards.
Draft instructions for First Article Inspections to validate initial production runs.
Evaluate nonconforming items, determine their disposition, and assist in resolving quality-related issues.
Manage nonconformity and CAPA processes, including investigations, corrective actions, and effectiveness checks.
Drive product and process enhancements using CAPA and Kaizen principles.
Serve as the subject matter expert for projects involving new equipment, product launches, or process upgrades.
Assist in preparing for internal and external audits by conducting Gemba walks and implementing remediation steps.
Conduct risk assessments for manufacturing processes to identify and mitigate potential issues.
Requirements
Proven background in manufacturing, quality assurance, or engineering.
Hands-on experience working within ISO 13485 and 21CFR820 regulated medical device environments.
Strong capabilities in data interpretation, problem-solving, and analytical thinking.
Ability to collaborate effectively across different functional teams.
Meticulous attention to detail with a firm commitment to maintaining high quality standards.
Strict adherence to established procedures, safety protocols, and security requirements.
Nice to have
A bachelor’s degree or equivalent combination of education and practical experience.
Prior exposure to CNC machining and surface treatment processes.
Familiarity with production and quality management systems such as MES, SAP, ETQ, or Babtec.
Knowledge of statistical analysis methods, including SPC and capability studies.
What the company offers
A dynamic and responsible role within a global organization that maintains a strong local footprint.
Competitive employment terms with opportunities for long-term career growth.
Significant autonomy and personal responsibility in daily tasks.
An environment that encourages creative thinking and continuous learning.
Performance-based bonuses, additional vacation days, and various other benefits.
Quelle: öffentlich zugängliche Karriereseite des Arbeitgebers. Batchly ist nicht der Arbeitgeber und steht nicht notwendigerweise in einem Vertragsverhältnis mit dem Unternehmen.