Senior Mechanical Engineer
2 weeks ago
Senior Engineer, Mechanical – Supplier Quality
Key Responsibilities
As a Senior Engineer specializing in Supplier Quality, you will serve as the primary representative for quality assurance at our manufacturing facility. Your role will involve overseeing the quality of incoming materials by addressing supplier non-conformances and implementing corrective actions. You will be responsible for managing supplier change notifications, conducting performance reviews, and generating reports and scorecards to track supplier performance.
You will provide support for critical issues such as product recalls, field alerts, and customer complaints, ensuring that all actions align with regulatory requirements. Your expertise will be essential in maintaining the Approved Supplier List (ASL) and performing thorough supplier audits to ensure compliance with industry standards.
In this position, you will regularly collaborate with a diverse team across various functions, including Research & Development, Manufacturing Engineering, Operations, and Purchasing. Utilizing problem-solving methodologies, you will conduct root cause analyses to address quality issues effectively.
You will ensure adherence to Quality System Regulations and take ownership of non-conformance reports and corrective action plans from initiation through to resolution. Regular assessments of manufacturing areas will be conducted to identify compliance risks and propose necessary mitigations.
Additionally, you will engage with external suppliers to resolve quality-related challenges and prepare data analysis reports and presentations for leadership. Mentoring junior engineers in technical writing and quality assurance concepts will also be part of your responsibilities.
Qualifications and Experience
A Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a related field is required, along with a minimum of four years of relevant experience in a similar role.
Special Skills Required
Candidates must possess in-depth knowledge of the Medical Device Industry and FDA Quality System Regulations, including 21CFR820 and ISO13485. Proficiency in automation, medical device assembly, and manufacturing processes is essential, along with experience in conducting audits. Familiarity with Six Sigma methodologies and tools for root cause investigation is also required.
Strong skills in engineering technical writing and the ability to interpret engineering drawings are necessary. Knowledge of statistical analysis tools such as Minitab is advantageous.
ICU Medical, Inc. is committed to equal employment opportunities for all qualified individuals.
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