Sr. Quality Engineer

Cirtec Medical; Lowell (MA); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Training and career development

Healthcare and well-being programs

Paid Time Off

401(k) retirement savings with company

Job summary

Cirtec Medical is actively seeking a Senior Quality Engineer in Lowell, MA to strengthen quality engineering in new product development, operations, and quality systems. The role focuses on building robust processes that meet regulatory requirements and drive product quality across the site.

You will lead SOPs, QA plans, CAPA activities, IQ/OQ, and V&V efforts, while supporting supplier quality and audits. This position offers a pathway to advancing continuous improvement in a dynamic

Qualifications

• Bachelor’s degree in a STEM field; 5+ years experience.
• Experience in engineering with mechanical, tool design and manufacturing processes.
• Proficient in data analysis using computer systems (MS Office).
• Able to implement quality programs and present data to management.
• Promote process improvement and standards development.

Responsibilities

• Provide Quality Engineering support for development or production.
• Manage quality projects during product transfers from development to production.
• Own verification/validation master plan and determinations.
• Develop and maintain SOPs and Quality Plans.
• Develop protocols, perform analyses, and write validation reports.
• Support IQ/OQ protocols to ensure Quality System compliance.
• CAPA system owner and investigate CAPA activities.
• Interact with customers and suppliers to resolve CAPA issues.
• Provide QC support for NCR disposition.
• Review changes for quality requirements and compliance.
• Assist supplier quality activities and vendor performance.
• Audit support for third-party, customer and internal audits.
• Support continuous improvement initiatives.
• Develop and maintain production quality control plans.
• Initiate and maintain SPC for production processes.
• Lead or support FMEA and DOE as applicable.

Skills

Engineering experience

Mechanical design

Tool design

Manufacturing processes

MS Office

Data analysis

Quality programs

Process improvement

Standards development

Managing processes

Education

Bachelor’s degree in STEM

Tools

Minitab

Job description

About us

For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.

Description

For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.

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 challenges, you may be a perfect fit for our team!

Position Summary

The Senior Quality Engineer will develop, establish, and maintain quality engineering methodologies, systems and practices which meet customer and regulatory requirements. This role will be focused on providing quality engineering support to the new product development process, operations/production, and quality systems. This individual will also serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support site and corporate quality goals and priorities.

Key Responsibilities

• Provide Quality Engineering support for engineering product development, or sustained manufacturing.
• Provide Quality Project Management support as needed for product transfers from development to validation to production.
• Verification/Validation System Owner responsible for the development and management of the verification/validation master plan along with the verification/validation determination.
• Develop and maintain Standard Operating Procedures.
• Develop and maintain project Quality Plans for assigned projects.
• 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.
• CAPA (Corrective and Preventative Action) system owner or support responsible for the support of the corrective action system and procedures.
• 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.
• Develop quality systems and procedures as needed.
• Audit support for third party audits, customer audits and internal audits.
• Support the implementation of continuous improvement initiatives.
• Develop and maintain production quality control plans.
• Initiate and maintain SPC (Statistical Process Control) for production processes.
• Lead or support FMEA (Failure Modes & Effects Analysis), and DOE (Design of Experiment) as applicable.

Must Have

• A Bachelor’s degree in a STEM discipline and 5 years of experience required.
• Experience in an engineering environment with mechanical, tool design, and manufacturing processes.
• Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office.
• Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement.
• Must be able to analyze and process information; promote Process Improvement, Developing Standards, Managing Processes, Manufacturing Methods, and Procedures; and Support Innovation.

Good To Have

• Medical device experience preferred.
• Minitab experience desirable

Salary Range

$100,000-$130,000

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, 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.