Careers with an impact

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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.

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 members are passionate about growth, innovation and collaboration. We are constantly striving to improve and better ourselves so that we can better support our clients. If you have growth mindset and find challenges motivating, then you are probably a great fit for our team!

This position is based in Lowell, MA.

A day as a Sr. Quality Engineer in Cirtec Medical

You will develop, establish, and maintain quality engineering methodologies, systems and practices which meet customer and regulatory requirements. You will also focus on providing support to the new product development process, operations/production, and quality systems while improving awareness, visibility, and communication on quality initiatives.

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

• Lead FMEA (Failure Modes & Effects Analysis), and DOE (Design of Experiment) as applicable
• Responsible for the Validation System for the development and management of the master plan along with the determination
• Audit support for third party audits, customer audits and internal audits.
• Support the implementation of continuous improvement initiatives.
• Initiate and maintain SPC (Statistical Process Control) for production processes
• 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.
• 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.

Key areas of expertise are:

• Project / program management skills,
• Relationship building / customer engagement skills
• Strong problem solving and collaboration skills, demonstrated through successful negotiations and positive outcomes.

Must Have:

• Relevant Bachelor of Science degree, preferably in an engineering discipline
• Minimum 5 year's experience in medical manufacturing environment.
• Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement

Good to have:

• Ability to adapt to a changing environment and handle multiple priorities
• 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.
• Strong analytical and communication 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 Cirtec’s 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.