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Form of workDescription
Job Title
Sr. Hardware Quality Engineer
FLSA Status
Exempt
Position Summary
Provide quality support for ICU Medical Hardware and development. 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 for the system (includes aspects of electro-mechanical, software and consumable components) product lines. 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. He / She will work directly on new product development and on-market sustaining engineering teams.
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 brining 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 & Qualifications
• 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:
o ISO 13485
o ISO 14971
o IEC 60601
• 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
Education and Experience
• Bachelor's degree in engineering (Electrical, Mechanical, Biomedical) or related field from an accredited college or university is required.
• Master's degree preferred.
• 7+ years' experience in R&D or Quality is required.
• ASQ CQE certification required or the ability to obtain within one year.
Minimum Qualifications
• Must be at least 18 years of age
• Must pass pre-employment drug screen and background check
Travel Requirements
• Typically requires travel 5% to 10% of the time
Physical Requirements and Work Environment
• This is largely a sedentary role.
• This job operates in a professional office environment and routinely uses standard office equipment.
ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Job Title
Sr. Hardware Quality Engineer
FLSA Status
Exempt
Position Summary
Provide quality support for ICU Medical Hardware and development. 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 for the system (includes aspects of electro-mechanical, software and consumable components) product lines. 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. He / She will work directly on new product development and on-market sustaining engineering teams.
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 brining 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 & Qualifications
• 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:
o ISO 13485
o ISO 14971
o IEC 60601
• 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
Education and Experience
• Bachelor's degree in engineering (Electrical, Mechanical, Biomedical) or related field from an accredited college or university is required.
• Master's degree preferred.
• 7+ years' experience in R&D or Quality is required.
• ASQ CQE certification required or the ability to obtain within one year.
Minimum Qualifications
• Must be at least 18 years of age
• Must pass pre-employment drug screen and background check
Travel Requirements
• Typically requires travel 5% to 10% of the time
Physical Requirements and Work Environment
• This is largely a sedentary role.
• This job operates in a professional office environment and routinely uses standard office equipment.
ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
