Process Quality Engineer

We are searching for the best talent for Process Quality Engineer.

Purpose:
The Quality Engineer applies Quality Engineering tools and practices to support the effective and efficient development, transfer, and maintenance of products and processes throughout the product lifecycle. In this role, we rely on your problem‑solving skills and quality mindset to improve processes aligned with our Quality and Business vision. The position applies appropriate risk management to prevent unanticipated failure modes, improve process capability, and support base business operations.

You will be responsible for:

• Supporting quality improvement initiatives, including process and product characterization, that drive continuous improvement and cost efficiency
• Supporting process verification and validation activities across the product lifecycle
• Reviewing and analyzing the effectiveness of PDCA, Six Sigma, Kaizen, Lean techniques, and other improvement tools
• Reviewing and analyzing product and process compliance with applicable standards and regulations, including QSRs and ISO 13485
• Championing compliance with global regulations and standards (e.g., QSRs, ISO, EN, MDD) and supporting internal and external audits
• Partnering with R&D and cross‑functional teams to ensure effective application of design controls, risk management, and investigation of design challenges
• Supporting new product introductions as part of design transfer activities
• Conducting investigations, documentation, review, and approval of non‑conformances, CAPAs, and customer complaints, including appropriate escalation of quality issues
• Owning and monitoring quality metrics, including leading and lagging indicators
• Collecting and analyzing data using statistical and analytical methods to support process improvements and day‑to‑day decision‑making
• Developing, interpreting, and implementing standard and non‑standard sampling plans
• Assessing the effectiveness of measurement tools, destructive and non‑destructive testing, and measurement system analyses
• Evaluating risk mitigation strategies based on product classification, defect types, frequency, severity, patient risk, and process capability
• Following all company guidelines related to Health, Safety, and Environmental practices

Qualifications / Requirements:

• A minimum of a degree or equivalent experience, preferably in Engineering or a related technical field
• Experience working in manufacturing or operations environments
• Knowledge of product and process risk management in accordance with FDA and ISO standards
• Experience implementing appropriate risk mitigation strategies
• Experience working in both FDA and European regulatory environments is preferred
• Technical training or experience in Statistics, Lean, and Six Sigma methodologies, including SPC, MSA, DOEs, and reliability tools
• Demonstrated understanding of AI concepts and frameworks, including responsible and ethical AI practices, with experience using effective prompt generation to improve efficiency and productivity

We are committed to providing an inclusive and supportive work environment.
We offer competitive compensation and a comprehensive benefits package, along with opportunities for learning, development, and career growth. We are an equal opportunity employer and provide reasonable accommodations throughout the recruitment process.

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