Sr. Engineer, Quality

Department: NC - Quality

Location: Brooklyn Park, MN

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ABOUT THE COMPANY

Cirtec Medical is more than just another design shop or contract manufacturer, we offer a uniquely comprehensive range of vertically integrated capabilities. Cirtec Medical 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!

You are a part of:

The NovelCath team consists of engineers with diverse backgrounds and expertise. The NovelCath team works in close collaboration with Operations, R&D, and Purchasing. You will be involved focused on providing quality engineering support to the new product development process, operations/production, and quality systems. This individual will also serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support site and corporate quality goals and priorities.

JOB SUMMARY

The Senior Quality Engineer will develop, establish, and maintain quality engineering methodologies, systems and practices which meet customer and regulatory requirements.

ESSENTIAL RESPONSIBILITIES

• Provide Quality Engineering support for engineering product development, or sustained manufacturing.

• Provide Quality Project Management support as needed for product transfers from development to validation to production.

• Verification/Validation System Owner responsible for the development and management of the verification/validation master plan along with the verification/validation determination.

• Develop and maintain Standard Operating Procedures.

• Develop and maintain project Quality Plans for assigned projects.

• Develop protocols, perform statistical analyses, and write reports for validations and formal product/process development, which requires quality-engineering involvement.

• Support the development and implementation of IQ (Installation Qualification) and OQ (Operational Qualification) protocols to ensure compliance with the Quality System.

• Provide Quality Engineering support for engineering/manufacturing.

• CAPA (Corrective and Preventative Action) system owner or support responsible for the support of the corrective action system and procedures.

• Interact with customers and suppliers to resolve CAPA and complaint investigations.

• Provide Quality Support for the disposition of material via NCRs.

• Support supplier quality activities including vendor approval and maintaining and assessing vendor performance data (i.e. SCAR/on time).

• Review and document procedure changes for quality requirements and compliance with the quality system.

• Develop quality systems and procedures as needed.

• Audit support for third party audits, customer audits and internal audits.

• Support the implementation of continuous improvement initiatives.

• Develop and maintain production quality control plans.

• Initiate and maintain SPC (Statistical Process Control) for production processes.

• Lead or support FMEA (Failure Modes & Effects Analysis), and DOE (Design of Experiment) as applicable.

• May serve as backup to Quality Manager.

• Complies with company, quality, and safety standards, policies, and procedures.

• Other duties as assigned.

This is not a remote position.

An individual in this position must be able to successfully perform the essential duties and responsibilities

listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform

the essential functions of this position.

QUALIFICATIONS

• A Bachelor-s degree (STEM engineering discipline preferred) and 5 years of experience required; or a combination of education and relevant work experience.

• Experience in an engineering environment with mechanical, tool design, and manufacturing processes (medical device preferred).

• Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office.

• Must possess excellent verbal communication, organizational and management skills.

• Training or equivalent experience in computer use and software-Microsoft Word, Excel, Power Point and Access. Minitab experience desirable.

• Must be able to read, write and speak fluent English.

• Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement.

• Must be able to analyze and process information; promote Process Improvement, Developing Standards, Managing Processes, Manufacturing Methods, and Procedures; and Supports Innovation.

WHAT WE OFFER

• A fast-paced work environment

• Paid time off

• 401(k) retirement savings with a company match

• Clean, and well-lit production areas

• Training and career development, with onboarding programs for new employees and tuition assistance

• Financial security through competitive compensation, incentives and retirement plans

• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

WORKING ENVIRONMENT

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 an individual encounters

while performing the essential functions of this 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.

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