Senior Quality Engineer, Design Tiempo Completo

Position Summary
Provide quality support for ICU Medical Product and Development and design changes. The Sr. Quality Engineer will be responsible for development procedures and deliverables, ensuring their 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 Sr. Quality Engineer will provide quality assurance support for product realization/manufacturing teams. Reporting to the Quality Manager, this individual will be the Quality Core Team Member for ensuring products are developed/manufactured utilizing appropriate processes to design the highest level of quality into products as they are developed.
Essential Duties & 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.
Assures 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.
Provides compliance guidance concerning development, application, and maintenance of quality standards as related to product development within the quality system.
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.
Ensure compliance, alignment and consistency with ICU Medical’s quality system.
Prepare, support and ensure the readiness for any potential internal and/or external audits and inspections.
Knowledge & Skills
Expert quality compliance, audit, and investigation skills
In depth deep and broad knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, Complaints, Document Control, etc.)
Strong knowledge of medical device standards, including but not limited to:
ISO 13485
ISO 14971
In depth experience with and knowledge of FDA, MDR, and other key medical device regulations
Well-developed ability to take a systems approach and to understand the interaction between components (i.e. hardware, software, consumables)
Proven ability to work closely with engineering and manufacturing team members
Minimum Qualifications, Education & Experience
Must be at least 18 years of age
Bachelor’s degree in engineering (Electrical, Mechanical, Biomedical, Software) or related field from an accredited college or university is required.
Minimum of 7+ years of experience in R&D or Quality is required
ASQ CQE or CSQE required or the ability to obtain within one year.

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