Quality Systems Engineer I

2 days ago

Brooklyn Park, United States Cirtec Medical Full time

About us:

For over three decades, Cirtec Medical has been a leading provider of manufacturing solutions for complex Class II and III medical devices. We specialize in providing comprehensive services from design and development to manufacturing and finished device assembly. Our expertise spans active implants and neuromodulation, interventional cardiology, structural heart, minimally invasive surgical systems, smart orthopedics, and precision components.

Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenge, you may be a perfect fit for our team

Position Summary:

The Engineer, Quality Systems position will be responsible for ensuring operational adherence and compliance to Cirtec Medical's Quality Management System (QMS) requirements. This role will be expected to provide input on, and contribute to, development and implementation of Quality System improvement strategies and approaches.

Key Responsibilities:

  • Corrective/Preventive Actions (CAPA): Responsible for CAPA system administration, tracking individual CAPAs, and, as necessary, performing work on individual CAPAs.
  • Complaints Investigation/Returned Materials Analysis: Knowledge of process(es) for investigation/analysis of returned/complaint materials.
  • Nonconforming Material (NCM) Control: Knowledge of ID, traceability, containment requirements, Material Review Board (MRB) responsibilities and handling of NCM.
  • Supplier Quality Management: Support Qualification activities and maintenance of the Approved Supplier List (ASL). Support management of Supplier/vendor Corrective Actions (SCAR).
  • Internal Auditing: Responsible for the system to ensure all internal audits are performed as scheduled. Assess compliance to FDA and ISO 13485 requirements, as well as the internal Quality System, including investigation observations/findings and reporting.
  • Documentation Control: Support local Document Control (PLM) and Material Resource Planning (MRP) systems.
  • Support Preventive Maintenance, Calibration & Metrology.
  • Support Equipment Qualifications and Test Method Validations.
  • Support generation of Quality Plans for the QMS and Organizational Objectives projects.
  • Measure and report quality system metrics providing statistical data/trending analysis, etc.
  • Support Corporate Quality Management System initiatives and continuous improvement activities.
  • Provide support for generation, tracking/trending & reporting of quality system metrics, as required.
  • Support and maintain ISO Class clean rooms (review/trending of testing and monitoring reports).
  • Support site customer-requested auditing activities (Customer and Regulatory Agencies).
  • Ensure compliance of all site personnel to Corporate and site-level QMS requirements.
  • Ensure adherence to training requirements regarding Quality Management System elements, controls, processes, and procedures.
  • Complies with company, quality, and safety standards, policies, and procedures.
  • Other duties as assigned.

Must Have:

  • Bachelor's Degree required with 0 years of experience, or a combination of education and relevant work experience.
  • Quality certification(s) (e.g., ASQ CQT, QCI, etc.).
  • Class I, II and/or III Medical Device manufacturing experience.
  • Knowledge of selection and testing methodology to define and collect data to support accuracy, reliability, and capability for purpose of measurement and test equipment.
  • Knowledge and experience with external standards: ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints.
  • Excellent verbal and writing skills using the English language.
  • Must be fluent in use of computer systems and database management, specifically Microsoft Office.
  • Technical degree, training or equivalent in experience in computer use and software-Microsoft Word, Excel, Power Point and Access.
  • Must be able to read, write and speak fluent English.
  • Need to be able to interpret technical drawings, specifications, and illustrations.
  • Must have working knowledge of Quality Systems Management and Master Control, Oracle, and/or equivalent document management system.

Cirtec Medical Corporation considers everyone 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 its related companies fully endorse equal opportunity. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec's goal to create an enjoyable work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life. Our benefits include training and career development, healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.

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