Senior Engineer, Design Quality - 24300086-8088 - ICU Medical, Inc.
Lake Forest, IL
About the Job
This job was posted by https://illinoisjoblink.illinois.gov : For more
information, please see:
https://illinoisjoblink.illinois.gov/jobs/12205722 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 E vironment
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.
information, please see:
https://illinoisjoblink.illinois.gov/jobs/12205722 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 E vironment
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.
Source : ICU Medical, Inc.
