Quality Engineer II

CAREERS WITH AN IMPACT

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 todays most advanced product technologies including, neuromodulation, implantable drug delivery, cardiac rhythm management, ventricular assist and interventional devices and delivery systems.

Cirtec Medical Lowell - provides innovative single and multi-layer thin-film circuits and components for medical devices and other critical applications.

Our Culture

• Our team is dedicated to fostering growth, innovation, and collaboration. We consistently seek opportunities for improvement to enhance our ability to assist clients. If you embrace a growth mindset and find motivation in challenges, you likely a great fit for our team!

This position is based in Lowell, MA.

Sign-On Bonus

• To demonstrate our commitment to attracting top talent, we are offering a sign-on bonus to the successful candidate.

A day as a Quality Engineer II in Cirtec Medical

You will be responsible for monitoring and auditing the quality of all manufactured goods in a medical device industry. You will find areas of improvement and develop a solution. Additionally you will interact with customers and suppliers in support of engineering projects.

Responsibilities may include the following and other duties may be assigned:

Key areas of expertise are:

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

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

• Provide initiative and support for FMECA (Failure Modes & Effects Criticality Analysis), and DOE (Design of Experiment as applicable.

• Develop and maintain project Quality Plan for assigned projects.

• 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 manufacturing.

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

• Interact with customers and suppliers to resolve CAPA and complaint investigations and in support of manufacturing.

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

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

• Comply with all work rules including those pertaining to safety, health, quality and Cirtec policies.

Must Have:

• Bachelor degree required, preferably in an engineering discipline.

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

Good to have:

• Analyze and process Information, Promote Process Improvement, Developing Standards, Managing Processes, Manufacturing Methods and Procedures, Supports Innovation.

• Minimum experience in medical/manufacturing environment: 2-5 years

• If you're the right person for this opportunity, you will have previous experience providing administrative support to a busy office and using Microsoft Office.

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

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.

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 Cirtecs goal to create a great 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 career and life stage. Our benefits include; Training and career development, Health care 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.