Sr. Engineer, Quality

2 weeks ago

Minneapolis, United States Cirtec Medical Corporation Full time
Job DescriptionJob Description

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.

  • Sr. Mechanical Engineer

    2 months ago

    Minneapolis, United States Apollo Professional Solutions Full time

    Job DescriptionSr. Mechanical Engineer Pay Rate: $58.28 Benefits: Heathcare, Dental, Vision, and 401k Schedule: Day, 9/80 workweek (every other Friday off) Sr. Mechanical Engineer - JOB DESCRIPTION:Researches, plans, analyzes, designs, and develops mechanical products such as ammunition handling systems, structures, gun systems, missile launchers,...

  • Sr. Technology Engineer

    4 weeks ago

    Minneapolis, United States Infinity Consulting Solutions Full time

    We have partnered with our client in their search for a Sr. Technology Engineer role. This person will be responsible for helping firms to configure their technology tools to best suit their firm, advisor and client needs. This role participates in the onboarding of new clients and technology tools, with additional project work to execute on the technology...

  • Senior Quality Engineer

    4 weeks ago

    Minneapolis, United States EPM Scientific Full time

    Summary: The Quality Engineer will lead efforts to maintain a culture focused on quality and continuous improvement across all departments. This role ensures that customer, company, and regulatory requirements are met while balancing cost and productivity goals. The Quality Engineer is responsible for developing, improving, and qualifying manufacturing and...

  • Senior Quality Engineer

    3 weeks ago

    Minneapolis, United States EPM Scientific Full time

    Summary: The Quality Engineer will lead efforts to maintain a culture focused on quality and continuous improvement across all departments. This role ensures that customer, company, and regulatory requirements are met while balancing cost and productivity goals. The Quality Engineer is responsible for developing, improving, and qualifying manufacturing and...

  • Sr Engineer

    1 month ago

    Minneapolis, Minnesota, United States Genesis10 Full time

    Genesis10 is seeking a Sr Engineer for a contract with our client in Minneapolis, MN. 100% Remote.Job Description:As a Sr Engineer you will be considered a technical expert in one or more phases of application and/or systems engineering. This includes providing design recommendations based on long-term IT organization strategy and expertise regarding the...

  • Sr. Software Engineer

    2 months ago

    Minneapolis, Minnesota, United States Royal Bank of Canada Full time

    Job Summary Exciting Opportunity as a Sr. Software Engineer at RBC Capital Markets, LLC Design innovative real-time and batch MuleSoft APIs for seamless integration with Salesforce and other backend systems. Collaborate with backend teams to troubleshoot and resolve issues with source systems. Take part in defining the MuleSoft architecture direction...

  • Sr Advanced Manufacturing Engineer

    2 days ago

    minneapolis, United States BEPC Inc. - Business Excellence Professional Consulting Full time

    BEPC has an open position for a Sr Advanced Manufacturing Engineer in Minneapolis, MN! Contract W2 Period: 5-month contract with possibilities for extensions Pay & Benefits: $50.00 - $60.00/hr. +Medical, Dental, Vision and Life InsurancePAY RATE: $50-60/hr, based on skills and experience Description:Our team develops new or modifies processes, defines...

  • Sr Advanced Manufacturing Engineer

    2 days ago

    minneapolis, United States BEPC Inc. - Business Excellence Professional Consulting Full time

    BEPC has an open position for a Sr Advanced Manufacturing Engineer in Minneapolis, MN! Contract W2 Period: 5-month contract with possibilities for extensions Pay & Benefits: $50.00 - $60.00/hr. +Medical, Dental, Vision and Life InsurancePAY RATE: $50-60/hr, based on skills and experience Description:Our team develops new or modifies processes, defines...

  • Sr Advanced Manufacturing Engineer

    4 days ago

    Minneapolis, United States BEPC Inc. - Business Excellence Professional Consulting Full time

    BEPC has an open position for a Sr Advanced Manufacturing Engineer in Minneapolis, MN! Contract W2 Period: 5-month contract with possibilities for extensions Pay & Benefits: $50.00 - $60.00/hr. +Medical, Dental, Vision and Life InsurancePAY RATE: $50-60/hr, based on skills and experience Description:Our team develops new or modifies processes, defines...

  • US - Sr Adv Advanced Manufacturing Engineer

    6 days ago

    Minneapolis, United States Experis Full time

    Our client, Aerospace Manufacturer is seeking a Sr Adv Manufacturing Engineer to join their team. As a Sr Adv Manufacturing Engineer, you will be part of the Manufacturing Department supporting. The ideal candidate will have Root Cause Corrective Action / Lean / Six Sigma, Manufacturing which will align successfully in the organization.   Job Title: Sr...

  • Sr. Customer Quality Engineer

    2 weeks ago

    Minneapolis, United States Detector Electronics LLC Full time $85,000 - $115,000

    Job DescriptionJob DescriptionSpectrum Safety Solutions:With approximately 1,400 employees operating in more than 20 countries, Spectrum Safety Solutions is a global leader in fire detection and suppression solutions for high-hazard applications across verticals such as critical infrastructure, oil and gas, marine and clean energy. Our global team leverages...

  • SR Mobile Automation Engineer

    4 weeks ago

    Minneapolis, United States Cognizant Full time

    Cognizant Technology Solutions is looking for “SR .Mobile Automation Engineer ” to join in our team of IT professionals in a permanent role. If you meet our background requirements and skills and are looking for an opportunity with these skills and expertise, here is the ideal opportunity for you! About Cognizant’s QEA Practice: About Cognizant’s QEA...

  • Sr. Manufacturing Engineer

    3 weeks ago

    Minneapolis, United States Planet Pharma Full time

    Sr. Manufacturing EngineerPlymouth MN12 month extendable contract40-50/hrResponsibilities may include the following and other duties may be assigned. Designs manufacturing processes procedures and production layouts for assemblies equipment installation processing machining and material handling. Designs arrangement of machines within plant facilities to...

  • US - Sr Adv Advanced Manufacturing Engineer

    6 days ago

    Minneapolis, United States Experis Full time

    Our client, Aerospace Manufacturer is seeking a Sr Adv Manufacturing Engineer to join their team. As a Sr Adv Manufacturing Engineer, you will be part of the Manufacturing Department supporting. The ideal candidate will have Root Cause Corrective Action / Lean / Six Sigma, Manufacturing which will align successfully in the organization. Job Title: Sr Adv...

  • Sr Quality Systems Specialist

    4 weeks ago

    Minneapolis, United States Three Point Solutions Full time

    Job DescriptionJob DescriptionJob Title: Sr Quality Systems Specialist Client: Medical Device Manufacturing Company Duration: 7 months Location: Minneapolis, Minnesota 55432 Shift: 1st ShiftHM's Top Needs:(Strong Preference) Candidate has experience working in MAP Agile or Windchill.Candidate has excellent communication and interpersonal skills, working...

  • Sr Quality Systems Specialist

    3 weeks ago

    Minneapolis, United States Three Point Solutions Full time

    Job DescriptionJob DescriptionJob Title: Sr Quality Systems Specialist Client: Medical Device Manufacturing Company Duration: 7 months Location: Minneapolis, Minnesota 55432 Shift: 1st Shift(20 hours per week is planned) (On site (our current requirement at Rice Creek is 3 days/week in office, so I think we'd want them to be on site for all their...

  • Sr AI Engineer MLOps

    3 days ago

    Minneapolis, United States UrBench Full time

    Sr. AI Engineer (MLOps) Customer Complaint (Over 10 yrs) Preferred Location: Minneapolis Chicago Seattle or Bay Area Long term contract Design develop and implement machine learning algorithms and artificial intelligence systems to solve complex problems. Work on data preprocessing feature engineering model training evaluation deployment and model...

  • Sr. Full Stack Engineer

    2 weeks ago

    Minneapolis, United States Ovativegroup Full time

    About Ovative Group: Ovative Group is the premier independent media and measurement firm in the United States. We help trailblazers in fast-growing, customer-centric organizations across industries reinvent their marketing and measurement programs. We leverage our media, measurement, and consulting capabilities to help brands like Domino's, Facebook, The...

  • Sr. Engineering Program Manager

    2 weeks ago

    Minneapolis, United States Redbock - an NES Fircroft company Full time

    **Only considering candidates who can work on a W2 basis with our organization. Pass through relationships will not be considered either**Sr. Engineering Program Manager (12-month contract // Minneapolis, MN):Hybrid, 3 days per week onsiteTop 3 Skills:Project Management Expertise (tools, paradigms, and experiences)Communication – Solid written and verbal...

  • Sr. Engineering Program Manager

    2 weeks ago

    Minneapolis, United States Redbock - an NES Fircroft company Full time

    **Only considering candidates who can work on a W2 basis with our organization. Pass through relationships will not be considered either**Sr. Engineering Program Manager (12-month contract // Minneapolis, MN):Hybrid, 3 days per week onsiteTop 3 Skills:Project Management Expertise (tools, paradigms, and experiences)Communication – Solid written and verbal...