Principal Quality Engineer - Catheter

Department: Quality Control

Location: Santa Clara, CA

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JOB SUMMARY

The Pr. 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 leading quality engineering support to the new product development process, operations/production, and quality systems. This individual will also serve as the lead Quality representative to improve awareness, visibility, and communication on quality initiatives to support site and corporate quality goals and priorities.

ESSENTIAL RESPONSIBILITIES

• This position may have direct-reporting responsibilities for daily activities of site Quality personnel. This position may be the backup to site management representative.

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

• Provide direction in implementing Incoming Inspection, First Article Inspection, In-Process and Final Product Inspection plans

• Develop and justify appropriate sampling plans with characterization of test/inspection methods.

• Author, review and/or approve documentation for Design Control activities for Design and Project Phase Reviews as well as Product Verification testing in cooperation with cross-functional engineering teams per project requirements.

• Assist in qualification activities associated with supplier/vendor design characterization requirements for projects, to include audits and assessments

• Provide Leadership Engineering Technical Expertise and Guidance for site-level Quality functions.

• Support and enforce Quality Best Practices and GDP/GMP continuous improvement efforts.

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including CAPA-s, CCR-s and NCMR-s.

• 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.

• Ensure compliance of all site personnel to Corporate and site-level QMS and training requirements.

• Administration of employment practices, which includes, but is not limited to, monitoring time & attendance, hiring, terminating, counseling and disciplinary actions for all employees. Responsible to ensure these actions are performed in compliance with Federal, local, and organizational laws/policies.

• 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.

• Approve disposition of material via NCRs.

• Own or approve 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 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.

• 10 years minimum experience in medical device environment, catheter experience preferred. Or combination of education and relevant work experience.

• 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 $125,000-187,000. 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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