Senior Quality Engineer

Cirtec Services GmbH; Santa Clara (CA); On-site; USD 120,000 - 150,000; Full time

Job summary

Cirtec Medical Corporation is seeking a Senior Quality Engineer to develop and maintain quality engineering methodologies aligned with customer and regulatory requirements. You will support new product development, operations, and quality systems while acting as a quality representative to drive improvements.

The role emphasizes CAPA ownership, V&V activities, and collaboration with engineering and manufacturing teams, with a pay range of $120,000–$150,000 per year and on-site work in Santa

Qualifications

• Bachelor's degree in a STEM engineering discipline.
• 5 years of engineering experience with mechanical, tool design and manufacturing processes (medical device preferred).
• Proficient in data analysis and Microsoft Office tools.
• Excellent verbal communication, organizational and management skills.
• Minitab experience desirable.

Responsibilities

• Provide Quality Engineering support for engineering product development or manufacturing.
• Provide Quality Project Management support for product transfers from development to production.
• Verification/Validation System Owner for V&V master plan and determinations.
• Develop and maintain SOPs and project Quality Plans.
• Develop protocols, perform analyses, and write reports for validations and development.
• Support IQ/OQ protocols to ensure quality system compliance.
• Provide Quality Engineering support for engineering/manufacturing.
• CAPA system owner or support for corrective actions.
• Interact with customers and suppliers to resolve CAPA and investigations.
• Provide quality disposition for material via NCRs.
• Support supplier quality activities including vendor approval and performance data.
• Review and document procedure changes for quality requirements.
• Develop and maintain production quality control plans.
• Initiate and maintain SPC for production processes.
• Lead or support FMEA and DOE as applicable.
• May serve as backup to Quality Manager.

Skills

Quality engineering

Statistical analysis

Verbal communication

Education

Bachelor's degree in STEM engineering

Tools

Minitab

Excel

PowerPoint

Access

Word

Job description

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.

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!

Please note that sponsorship is not available for this role.

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.
• Provide Quality Engineering support for engineering/manufacturing.
• 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.
• May serve as backup to Quality Manager

Must Have:

• A Bachelor's degree (STEM engineering discipline)
• 5 years of experience in an engineering environment with mechanical, tool design, and manufacturing processes (medical device preferred).
• 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. Minitab experience desirable.
• Must be able to read, write and speak fluent English.
• 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 Supports Innovation.

The pay range for this role is $120,000 - $150,000 a year. The successful candidate's starting base pay will be determined based on job-related skills, experience, qualifications, work location and market conditions. The expected base pay range for this role may be modified based on market conditions.

This is not a remote position.

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

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.