Sr. Quality Engineer - Catheter

Department: Quality

Location: Santa Clara, CA

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JOB SUMMARY

The Sr. Catheter 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.

ESSENTIAL RESPONSIBILITIES

• Provide Quality Engineering support for engineering product development and sustained manufacturing of catheters

• Ensure quality requirements are communicated and met at suppliers

• Review manufacturing records to perform lot release activity for catheters, including COC issuance

• 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.

• Lead the development and implementation of IQ (Installation Qualification) and OQ (Operational Qualification) protocols, and equipment calibration/maintenance 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 supplier approval and maintaining and assessing supplier performance data (i.e. SCAR/on time).

• Provide audit support for third party audits, customer audits and internal audits.

• Support the implementation of continuous improvement initiatives.

• Develop and maintain supplier control plans.

• Initiate and maintain SPC (Statistical Process Control) for production processes

• Lead FMEA (Failure Modes & Effects Analysis), and DOE (Design of Experiment) as applicable

• Complies with company, quality and safety standards, policies, and procedures

• Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

QUALIFICATIONS

• Bachelor of Science, preferably in biomedical, mechanical, or materials engineering discipline.

• 5 years minimum experience in medical device environment, catheter experience 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 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.

PAY RANGE

The pay range for this role is $110,000 to $166,000. 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.

WORKING ENVIRONMENT

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.

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.

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