Quality Engineer

This is a onsite position in our office in Sturtevant, WI. Remote/Hybrid work not available.

ABOUT THE COMPANY

More than just another design shop or contract manufacturer, Cirtec offers a uniquely comprehensive range of vertically integrated capabilities. Cirtec specializes in complex, difficult to produce components and devices in today’s most advanced product technologies including, neuromodulation, implantable drug delivery, cardiac rhythm management, ventricular assist and interventional devices and delivery systems. We have the capabilities needed to bring products to full production, including assembly, packaging and testing, and in-house sterilization.

Our employees have the expertise needed to design innovative devices, solve complex design challenges, and help bring our customers’ devices to market. If you are interested in working in a fun, challenging, fast-paced environment with a company that is growing and providing leading edge technology, Cirtec is the company for you!

Job Title:

Quality Engineer

Location:

Sturtevant, WI

Department/Group:

Quality

Position/Classification Type:

Full-Time, Exempt

Reports To

Quality Manager

Direct Reports

None

Shift

1st

JOB SUMMARY

The Quality Engineer assures products, processes, and quality records conform to quality standards and establish compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by safety and meeting business needs. Lead on-time completion of Quality Assurance (QA) engineering deliverables within Manufacturing and New Product Introduction (NPI).

ESENTIAL RESPONSIBILITIES

• Process QA requests, ensuring timely responses are provided in alignment with quality goals and customer expectations.
• Lead meetings and communications for QA system information, concerns, and updates.
• Specialize in areas of quality control engineering, such as design, incoming material, process control, product evaluation, product reliability, inventory control, metrology, automated testing, software, and administrative applications.
• Work with Production on Continuous Improvement (CI) projects.
• Interpret and comply with Cirtec’s quality assurance standards.
• Analyze and investigate product complaints or reported internal or external quality issues to ensure closure in accordance with company guidelines and external regulatory and customer requirements.
• Must be able to work independently with minimal supervision to drive and execute directives efficiently and swiftly.
• Develop and improve existing process control documentation in partnership with Production and Engineering staff.
• Conversant with current Cirtec NPI/CAPA/Validation procedures and can lead investigations with cross functional teams internally and externally when needed.
• Participate in internal and external audits as needed.
• Cooperate with and demonstrate professional conduct with coworkers and managers.
• Meet Cirtec standards for quality and productivity.
• Complete various required paperwork and documentation error free while following Cirtec’s Good Documentation Practices.
• Follow all procedures for cleanroom operation, cleanroom attire, and contamination control.
• Follow all Cirtec procedures for traceability, line clearance, process control, safety, and housekeeping.

QUALIFICATIONS

• Minimum of 3 years of Quality experience
• Detailed knowledge of FDA 21 CFR 820, ISO 13485 and GMP.
• Robust functional knowledge of Failure Mode Effects Analysis (FMEA) and Production Part Approval Process (PPAP)
• Moderate statistical/data analysis and report writing skills.
• Need to be competent in using Microsoft Office applications and Mini-Tab is an advantage.
• Organization and time management skills are essential.
• Creativity, verbal and written communication skills, analytical and problem-solving ability
• Effectively represent Cirtec during customer projects and related activities
• Strong attention to detail
• Ability to multitask.
• Able to sit or stand for extended periods.
• Must be able to lift 20 pounds.
• Willing and able to problem solve when something is not working right.
• Good work ethic (comes to work and returns from lunch and breaks on time, works hard to reach work standards, tries to minimize waste)
• Team player that gets along well with others (respectful of supervisors and co-workers, helps others by helping and ideas when appropriate)
• Is proactive in identifying potential problems or opportunities to increase productivity and quality, decrease waste and improve morale.
• Follows through on tasks and other projects as assigned.
• Communicate effectively with Cirtec’s employees and Management.
• Demonstrates all the Cirtec corporate values
  • Our Customers
  • Innovation
  • Respect
  • Transparency
  • Our Employees
  • Communication

WHAT WE OFFER:

• Ability to work on cutting edge lifesaving products
• 401(k) retirement savings with a company match
• Training and career development
• Tuition assistance
• Health care and well-being programs including medical, dental, and vision
• Paid time off
• Sign-on and referral bonuses
• Employee appreciation events
• Employee recognition program
• Clean and well-lit production areas

WORKING ENVIROMENT:

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those individual encounters while performing the essential functions of this position.

All employees will be provided with training in working safely, evacuation procedures, accident reporting and other safety topics the company feels are necessary to ensure and maintain a safe work environment from hazards to the employee.
An employee who does not feel safe or recognizes an unsafe practice, should report it immediately to their supervisor as a recognized responsibility of the position.

EEO STATEMENT:

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.