Engineer I Quality Systems

Job Description

Job Description

This position is eligible for a $5,000 Sign-On Bonus

WHO WE ARE :

For over three decades, Cirtec has been an industry-leading outsource partner for complex medical devices. Cirtec Medical provides outsourcing solutions for Class II and III medical devices.

From design and development, to precision components and finished device assembly, Cirtec can help bring complex devices to market.

Cirtec's expertise includes neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.

OUR PEOPLE :

The key to our success is our employees. The extensive design, development and manufacturing experience they provide enables us to create cost-effective, innovative medical device solutions for our customers.

Our creative and innovative staff are expert problem solvers and understand the technical, practical and regulatory issues involved in bringing a new or next-generation product to market.

WHY WORK FOR CIRTEC :

With three locations in Brooklyn Park, MN, our employees have the satisfaction of knowing that the work they do helps patients live better, longer lives and their commitment and expertise have made the company it is today : An industry leading provider of life enhancing therapies.

JOB 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.

ESSENTIAL 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.

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.

WHAT YOU WOULD BRING :

• 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.

WHAT WE PROVIDE FOR YOU :

• Health care and well-being programs including medical, dental, vision, wellness, and Employee Assistance programs
• Paid time off
• Training and career development
• Employee recognition program
• Tuition assistance
• 401(k) retirement savings with a company match
• Clean, climate controlled and well-lit production areas

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.