TASKS
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Investigate defects in production, warehouse stock and returned products. Document nonconformities, including findings, photographs, part and batch details, and relevant ERP references. Coordinate the assignment of responsible owners and consistently follow up on outstanding actions.
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When additional defective parts are suspected, place the affected inventory on hold in Epicor and inspect it in full. Separate conforming and nonconforming parts, arrange the necessary inventory transactions and coordinate approved scrapping, including the required documentation.
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Conduct root cause analyses with the departments involved, using methods such as 5 Whys or Ishikawa diagrams. Develop immediate containment and corrective actions, take responsibility for their implementation and verification of effectiveness, and improve inspection processes and defect prevention.
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Collect the necessary evidence for supplier nonconformities and support Quality Management in preparing supplier corrective action requests (SCARs). Take responsibility for placing affected goods on hold, checking warehouse stock, coordinating rework and associated shipments, and receiving the goods back into inventory.
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Inspect incoming goods against current specifications, drawings and inspection plans, and ensure inspection results and part identification are documented for traceability. Assess unusual findings, coordinate additional inspections and escalate nonconformities as required.
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Handle technical investigations into Sphere nonconformities, verify defects, analyse root causes, document findings and coordinate appropriate actions with the Person Responsible for Regulatory Compliance (PRRC). Escalate recurring defects to Quality Management in a timely manner.
PROFILE
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Completed technical vocational training or a comparable qualification with practical inspection experience.
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At least three years of experience in quality inspection, incoming goods inspection or production-related quality assurance.
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Experience in handling nonconformities, complaints, root cause analyses and corrective actions, as well as working with ISO 13485 in the medical device industry.
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Confidence in interpreting technical drawings, specifications and inspection plans, and in using appropriate inspection and measuring equipment. Familiarity with inspection documentation and traceability.
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Proficiency in MS Office and in working with digital quality and ERP data. Knowledge of Dot Compliance, Epicor and statistical methods is an advantage.
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Good German and working English language skills. Further training in quality assurance or metrology, an advanced technical qualification or a university degree is desirable.
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A careful, analytical and independent approach to work, consistent follow-through on actions and clear communication. Teamwork, organisational skills and the ability to assert your position objectively complete your profile.