Highly Qualified Quality Engineer for Medical Devices
hace 4 horas
Icu Medical Tijuana seeks a Senior Quality Engineer to join our team.
About the Role:
The Senior Quality Engineer will be responsible for developing and implementing quality procedures and deliverables, ensuring compliance with Icu Medical quality system requirements and applicable regulations and standards (such as ISO 13485, ISO 14971, 21 CFR Part 820, and other applicable regulations and standards). The Senior Quality Engineer will provide quality assurance support for product realization/manufacturing teams.
Key Responsibilities:
- Effectively utilize quality tools and processes such as product and process controls, risk analysis/management tools, validation, design verification, investigations, CAPA data, etc. to assure product quality.
- Assure conformance with regulations of the FDA and other international regulatory agencies and may assist in providing responses to the FDA and other regulatory agencies with respect to medical device compliance.
- Work with cross-functional teams to coordinate product changes.
- Participate in design reviews, test readiness reviews, cross functional teams, risk assessments, design transfers, etc.
- Provide corporate quality support, guidance and direction for bringing on-market product issues to closure and escalating to senior management for support as necessary.
- Ensure that potential product and process risks are evaluated, prioritized, and mitigated to continuously improve product quality.
- Utilize a wide variety of data sources including product review, global complaints, manufacturing quality data, etc. Monitor product data to identify statistically significant trends and risks.
Requirements:
- Bachelor's degree in engineering (Electrical, Mechanical, Biomedical, Software) or related field from an accredited college or university is required.
- Minimum of 7+ years similar role in Medical Device Industry.
- ASQ CQE or CSQE required or the ability to obtain within one year.
- Strong knowledge of medical device standards, including but not limited to: ISO 13485, ISO 14971, FDA, MDR and other key medical device regulations.
- Excellent Bilingual Spanish/English verbal and written communication skills.
Estimated Salary Range:$80,000 - $110,000 per year, based on experience and qualifications.
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