Quality Manager - Cirtec Medical Corporation

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 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.

**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 Manager at Cirtec Medical

You will lead and manage Quality team and resources to ensure company compliance with internal Quality Management Systems. You will also oversee engineering activities that support sustaining manufacturing operations, and product development programs.

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

Key areas of expertise are:

• Quality System Oversight: Ensure compliance and management of the Quality Management System, establishing and maintaining processes in line with regulations and standards.

• Regulatory Compliance: Promote awareness of regulatory requirements and Quality Management System standards across the organization.

• Management and Reporting: Lead Management Review meetings, report Quality System performance, drive improvements, and analyze metrics.

• Quality Control Management: Supervise Quality Control staff, manage inspection activities, and oversee complaint analysis and corrective/preventive actions.

• Cross-Functional Leadership: Provide leadership, coaching, and guidance to Quality personnel and cross-functional teams, supporting Quality initiatives and representing Quality Engineering in development phases.

• Risk Management and Documentation: Collaborate in generating/update risk management documentation, perform qualifications/validations, and contribute to process and design change activities.

• Audits and Compliance: Manage external audits, oversee regulatory certifications, and support document control and records retention.

• Continuous Improvement: Drive corporate Quality Management System initiatives and champion best practices and cGMP standards within the organization.

• Metrology and Calibration: Manage metrology and calibration activities to ensure accuracy and compliance.

• Nonconformance and Training: Oversee nonconformance reviews, manage Quality Systems staff providing training and support for Documentation Control, Inspection, Complaint Analysis, and Corrective Action.

• Development and Transfers: Ensure accountability for Design Controls and DHF management, support development programs, and collaborate with cross-functional teams.

• Safety and Compliance: Adhere to company, safety, and quality standards, policies, and procedures.

Must Have:

• Relevant Bachelor’s degree of Science preferably in an engineering discipline or equivalent combination of education and experience

• Minimum 7 years of experience in a regulated medical device environment, preferably as a Sr or Principal Quality Engineer or Quality Manager, with supervisory and decision-making responsibilities.

• Quality and/or Regulatory certification(s) preferred (ASQ, Lead Auditor, etc.).

• Knowledge and experience with external standards and regulations: ISO 13485, and 21 CFR 820 (FDA cGMP/QSR), EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier auditing & management, quality control (GD&T, MRB, etc.), CAPA and customer complaints.

• Experience with Class II and Class III medical device development and manufacturing.

• Demonstrable knowledge and experience with Manufacturing Process tools/methodologies including:

• Process Change Assessment, Risk Management (Hazard Analysis), Process FMEA, Statistical Analysis, Process Qualification, Gauge R&R, and Inspection/Test Method Validation.

Good to have:

• Ability to adapt to a changing environment and handle multiple priorities.

• Manufacturing experience in Photolithography, Surface Mount Circuit Boards, or Solid State Batteries technologies.

• 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.

• “Hands-on” self-starter with ability to work both independently and as part of a team

• Experience in effectively managing audits by customers and regulatory agencies.

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

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.