Assignment Description:
We are looking for a Senior Supplier Development and Quality Engineer to join our dynamic team.
What you will work on:
- Collaborate with suppliers to contain quality issues and conduct root cause analysis using tools like 8D, 5-Why’s, and Fishbone diagrams, ensuring robust corrective measures to prevent recurrence.
- Develop and implement quality plans with suppliers, promoting a zero-defect culture that reduces the need for upstream inspection, enhances yield, and strengthens product quality.
- Build strong relationships with both internal teams (procurement, R&D, manufacturing, service) and external suppliers, ensuring clear understanding and adherence to customer requirements.
- Plan, conduct, and document Supplier First Article Inspections and Production Part Approval Processes for new or modified parts, ensuring compliance with specifications through rigorous inspection, process audits, and documentation reviews.
- Conduct supplier capability and compliance audits on-site, assessing Quality Management Systems (QMS), processes, and documentation per relevant standards (e.g., ISO13485, ISO9001), and escalate risks as needed.
- Document audit results, non-conformances, and improvement opportunities, ensuring follow-up for continuous enhancement of supplier performance.
- Lead supplier development initiatives toward achieving world-class Quality Management standards through training and coaching on best practices, such as LEAN, Six Sigma, Value Stream Mapping, Process Validation, and PFMEA.
- Participate actively in Product Creation, Product Change, and Maintenance Projects to ensure that supplier quality aligns with product requirements.
What you bring:
- A proactive, self-starting approach and the ability to work independently in a fast-paced environment.
- At least 5 years of experience in engineering, manufacturing, and supplier quality/development within a regulated industry.
- Solid knowledge of industry standards and regulations, including ISO13485, ISO9001, ISO14001, ISO14971, QSR 21, and CFR Part 820.
- Proficiency in quality tools and methodologies such as 8D analysis, 5-Why’s, Fishbone, LEAN, Six Sigma, DFM, DFA, and PFMEA.
- Strong auditing experience, preferably with Lead Auditor certification.
- Excellent command of both English and Swedish, in both written and spoken communication.
If this sounds interesting, please send your CV to cv@veritaz.se
