Quality Engineer II
The Quality Engineer II will utilize and maintain quality engineering systems and practices in collaboration with Agiliti manufacturing and design centers that meet and exceed internal, customer, and regulatory requirements.
Location for this role is flexible /can work remote when not traveling. Must be willing to travel to Design Center located in Milwaukee, WI and Manufacturing Sites in Kansas and California to participate in Design Reviews and other specific Design and Development Activities.
Primary Duties And Responsibilities
- Acts as a team member in supporting quality decisions and practices.
- Applies systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Applies statistical methodologies for assessment and to resolve potential product and quality system issues.
- Develops and maintains or supports the development of testing plans, models and methods for raw materials, materials in process, and finished goods.
- Collaborates with Design, Manufacturing, and Supply Chain teams ensuring adequacy of product specifications to select and monitor suppliers.
- Coordinates planning and execution of first article inspections and approvals.
- Coordinate planning, execution and maintenance of tooling verification and validations in conjunction with manufacturing and engineering teams.
- Leads activities to support medical device manufacturing, such as Risk Management, Process FMEA, and Quality Control Plans.
- Plans, develops, and oversees execution of Design verification and validation protocols.
- Leads advanced product quality planning activities and assists in preparing new product designs for certification testing.
- Participates in projects and cross functional teams. May lead mid-scale projects.
Experience
- Bachelor's Degree (BS) in Engineering, Scientific, or Technical related subject required.
- 3-7 yrs. of relevant experience, preferably in Design and Development in an ISO13485, FDA 21CFR820 and MDSAP regulated environment, mainly for the Design Controls process and requirements.
- ISO13485 and FDA 21CFR820 highly desired.
- Working knowledge and experience with metrology labs preferred and GD&T.
- Experience with medical device ISO14971 Risk Management.
- Previous working experience in a Design Quality Assurance role for medical device equipment is required.
- Working knowledge of IEC 60601-1 Safety standards preferred, but not required.
- Use of statistical analysis software for SPC & CPk Analysis
- Tooling and fixturing development and qualification (FAI and Gage R&R)
- Minimum 3 years of working experience with Corrective and Preventive Actions at the Design and Development phase of a product lifecycle.
Skills & Abilities
- Proficient computer skills in MS Office Suite, including MS Project and Visio.
- Working knowledge of CAD software preferred (i.e., SolidWorks, Autodesk, etc.)
- Strong analytical skills and attention to detail
- Strong technical writing skills and effective communication skills
- Strong presentation, facilitation, and project management skills
- High level knowledge of DFSS concepts and tools preferred, but not required.
This job description in no way states or implies these are the only duties to be performed by the employee in this position. It is not intended to give all the details or a step-by-step account of the way each procedure or task is performed. The incumbent is expected to perform other duties necessary for the effective operation of the department.
It is the policy of Agiliti to provide equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender identity, sex, sexual orientation, national origin, age, physical or mental disability, genetic information, marital status, status as a veteran, military service, or any other characteristic protected by applicable federal, state, or local civil rights laws.In addition, Agiliti will provide reasonable accommodations for qualified individuals with disabilities.
Agiliti strictly prohibits any form of retaliation against individuals who make good faith reports of alleged violations of this policy or who cooperate in Agiliti's investigation of such reports.Affirmative Action Policy Statements
Agiliti offers a robust suite of benefits for regular, full-time, non-union employees including: health insurance options for Medical, Dental & Vision plans, Short- and Long-Term Disability plans, Flexible Spending Accounts, Health Savings Accounts, Life Insurance Options, Paid Time Off, 401K Saving Plan with employer match, Employee Discounts, Tuition Reimbursement, Daily Pay program, Employee Assistance Program, and wellness programs.
Agiliti is an equal opportunity employer and provides reasonable accommodations to employees and applicants consistent with state and federal law.
If you require assistance with your application, please contact recruiting@agilitihealth.com.
Primary Job Location:
Home Office (KS)
Company:
Agiliti
Location State:
Kansas
Pay Range for All Remote Locations:
$65,269.15-$169,742.88
Quality Engineer II
The Quality Engineer II will utilize and maintain quality engineering systems and practices in collaboration with Agiliti manufacturing and design centers that meet and exceed internal, customer, and regulatory requirements.
Location for this role is flexible /can work remote when not traveling. Must be willing to travel to Design Center located in Milwaukee, WI and Manufacturing Sites in Kansas and California to participate in Design Reviews and other specific Design and Development Activities.
Primary Duties And Responsibilities
- Acts as a team member in supporting quality decisions and practices.
- Applies systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Applies statistical methodologies for assessment and to resolve potential product and quality system issues.
- Develops and maintains or supports the development of testing plans, models and methods for raw materials, materials in process, and finished goods.
- Collaborates with Design, Manufacturing, and Supply Chain teams ensuring adequacy of product specifications to select and monitor suppliers.
- Coordinates planning and execution of first article inspections and approvals.
- Coordinate planning, execution and maintenance of tooling verification and validations in conjunction with manufacturing and engineering teams.
- Leads activities to support medical device manufacturing, such as Risk Management, Process FMEA, and Quality Control Plans.
- Plans, develops, and oversees execution of Design verification and validation protocols.
- Leads advanced product quality planning activities and assists in preparing new product designs for certification testing.
- Participates in projects and cross functional teams. May lead mid-scale projects.
Experience
- Bachelor's Degree (BS) in Engineering, Scientific, or Technical related subject required.
- 3-7 yrs. of relevant experience, preferably in Design and Development in an ISO13485, FDA 21CFR820 and MDSAP regulated environment, mainly for the Design Controls process and requirements.
- ISO13485 and FDA 21CFR820 highly desired.
- Working knowledge and experience with metrology labs preferred and GD&T.
- Experience with medical device ISO14971 Risk Management.
- Previous working experience in a Design Quality Assurance role for medical device equipment is required.
- Working knowledge of IEC 60601-1 Safety standards preferred, but not required.
- Use of statistical analysis software for SPC & CPk Analysis
- Tooling and fixturing development and qualification (FAI and Gage R&R)
- Minimum 3 years of working experience with Corrective and Preventive Actions at the Design and Development phase of a product lifecycle.
Skills & Abilities
- Proficient computer skills in MS Office Suite, including MS Project and Visio.
- Working knowledge of CAD software preferred (i.e., SolidWorks, Autodesk, etc.)
- Strong analytical skills and attention to detail
- Strong technical writing skills and effective communication skills
- Strong presentation, facilitation, and project management skills
- High level knowledge of DFSS concepts and tools preferred, but not required.
This job description in no way states or implies these are the only duties to be performed by the employee in this position. It is not intended to give all the details or a step-by-step account of the way each procedure or task is performed. The incumbent is expected to perform other duties necessary for the effective operation of the department.
It is the policy of Agiliti to provide equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender identity, sex, sexual orientation, national origin, age, physical or mental disability, genetic information, marital status, status as a veteran, military service, or any other characteristic protected by applicable federal, state, or local civil rights laws.In addition, Agiliti will provide reasonable accommodations for qualified individuals with disabilities.
Agiliti strictly prohibits any form of retaliation against individuals who make good faith reports of alleged violations of this policy or who cooperate in Agiliti's investigation of such reports.Affirmative Action Policy Statements
Agiliti offers a robust suite of benefits for regular, full-time, non-union employees including: health insurance options for Medical, Dental & Vision plans, Short- and Long-Term Disability plans, Flexible Spending Accounts, Health Savings Accounts, Life Insurance Options, Paid Time Off, 401K Saving Plan with employer match, Employee Discounts, Tuition Reimbursement, Daily Pay program, Employee Assistance Program, and wellness programs.
Agiliti is an equal opportunity employer and provides reasonable accommodations to employees and applicants consistent with state and federal law.
If you require assistance with your application, please contact recruiting@agilitihealth.com.
Primary Job Location:
Home Office (KS)
Company:
Agiliti
Location State:
Kansas
Pay Range for All Remote Locations:
$65,269.15-$169,742.88
