Project Quality Engineer I

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.

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:
This role is primarily responsible for supporting the introduction of new products and processes, including transfers within sister sites or customer sites. This position is reporting to Quality Organization but actively working with the PM/NPI group.

Key responsibilities include participating in the development, documentation, and validation of new customer products and modifications to existing products. This entails defining requirements, establishing timelines, and determining deliverables. The role emphasizes process development, training production personnel, and preparing for process validation and manufacturing transfers.

Additionally, the position will collaborate with customers and suppliers to ensure successful execution of engineering projects.

Key Responsibilities:
Product Development and Transfer Support

• Provide Quality Engineering support for engineering project development and sustained manufacturing activities.
• Manage and oversee product transfers, from development to validation and from validation to production, ensuring seamless transitions and compliance with quality standards.
• Collaborate with cross-functional teams to define project requirements, establish timelines, and track deliverables while maintaining alignment with project budgets.

Validation and Process Control

• Act as the Validation System Owner, responsible for creating and managing the Validation Master Plan and determining validation requirements.
• Develop, implement, and maintain Validation Standard Operating Procedures (SOPs) and Validation Master Plans to support compliance.
• Design and execute validation protocols (IQ, OQ, and PQ), analyze results using statistical methods, and prepare detailed validation reports.
• Lead and support process development activities, including conducting Design of Experiments (DOE) and ensuring readiness for process validation and manufacturing.
• Establish and sustain Statistical Process Control (SPC) systems and lead Failure Modes & Effects Criticality Analysis (FMECA) and related risk assessment activities.

Compliance and Quality Management

• Develop and maintain comprehensive Quality Plans and production quality control plans for assigned projects.
• Oversee customer and regulatory audits, ensuring compliance and timely resolution of findings.
• Support the development and documentation of procedure changes to ensure alignment with quality and regulatory requirements.
• Lead and support company-wide corrective and preventive actions (CAPA), including ownership of the CAPA system, corrective action investigations, and procedure improvement.
• Manage disposition of non-conforming materials through the NCR system and ensure timely and effective closure.
• Support business initiatives by developing and implementing continuous improvement strategies for manufacturing and quality systems.

Vendor and Customer Relations

• Oversee vendor qualification processes, track and assess supplier performance (e.g., SCAR and on-time delivery metrics), and provide feedback to ensure consistent quality.
• Collaborate with customers and suppliers to resolve CAPA-related issues, address complaints, and provide engineering support for manufacturing needs.

Quality Systems and Documentation

• Act as a backup to the Quality Systems Administrator, ensuring continuity in systems operation and maintenance.
• Develop and document new quality-related systems and procedures as needed to streamline operations and enhance performance.

General Responsibilities

• Ensure compliance with all company quality, safety standards, policies, and regulatory requirements always.
• Perform other duties as required to support departmental and organizational goals.

This is not a remote position.

Must Have:

• Bachelor's degree in an engineering discipline.
• 0-1 years of experience.
• Desirable previous experience in the validation of new products and in product or process transfer between sites.
• Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office.
• Must possess excellent verbal communication, organizational and management skills.
• Training or equivalent experience in computer use and software-Microsoft Word, Excel, Power Point and Access.
• Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement.
• Knowledge in Microsoft Project or any other projects control tool desirable.
• High level of English.
• Passport and Visa are indispensable.

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.