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Principal Quality Assurance Consultant

2 months ago

Santa Clara, California, United States Cirtec Medical Corporation Full time
Job Overview

POSITION SUMMARY

The Principal Quality Engineer will be responsible for the development, establishment, and maintenance of quality engineering methodologies, systems, and practices that align with customer and regulatory standards. This role emphasizes leading quality engineering support throughout the new product development lifecycle, production operations, and quality systems. The individual will act as the primary Quality representative to enhance awareness, visibility, and communication regarding quality initiatives that support both site and corporate quality objectives.

KEY RESPONSIBILITIES

  • Oversee the daily activities of site Quality personnel, potentially serving as a backup to site management representatives.
  • Deliver Quality Engineering support for the development and ongoing manufacturing of catheter products.
  • Guide the implementation of Incoming Inspection, First Article Inspection, In-Process, and Final Product Inspection plans.
  • Develop and validate appropriate sampling plans along with the characterization of testing and inspection methods.
  • Draft, review, and approve documentation for Design Control activities, including Design and Project Phase Reviews and Product Verification testing in collaboration with cross-functional engineering teams.
  • Assist in supplier/vendor qualification activities, including audits and assessments related to design characterization requirements.
  • Provide technical expertise and leadership for site-level Quality functions.
  • Support and promote Quality Best Practices and continuous improvement initiatives.
  • Utilize systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues, including CAPA, CCR, and NCMR.
  • Ensure that quality requirements are effectively communicated and met by suppliers.
  • Review manufacturing records to facilitate lot release activities for catheters, including Certificate of Compliance issuance.
  • Offer Quality Project Management support for product transitions from development through validation to production.
  • Act as the Verification/Validation System Owner, responsible for the development and management of the verification/validation master plan.
  • Establish and maintain Standard Operating Procedures.
  • Formulate and maintain project Quality Plans for assigned initiatives.
  • Develop protocols, conduct statistical analyses, and prepare reports for validations and formal product/process development requiring quality engineering involvement.
  • Lead the creation and execution of Installation Qualification (IQ) and Operational Qualification (OQ) protocols, along with equipment calibration and maintenance to ensure compliance with the Quality System.
  • Ensure compliance of all site personnel with Corporate and site-level Quality Management System (QMS) and training requirements.
  • Administer employment practices, including monitoring time and attendance, hiring, and disciplinary actions, ensuring compliance with relevant laws and policies.
  • Support the Corrective and Preventative Action (CAPA) system, ensuring effective procedures are in place.
  • Engage with customers and suppliers to address CAPA and complaint investigations.
  • Approve material disposition through Non-Conformance Reports (NCRs).
  • Manage supplier quality activities, including supplier approval and performance assessment.
  • Provide audit support for third-party, customer, and internal audits.
  • Champion the implementation of continuous improvement initiatives.
  • Develop and maintain control plans.
  • Initiate and sustain Statistical Process Control (SPC) for production processes.
  • Lead Failure Modes and Effects Analysis (FMEA) and Design of Experiments (DOE) as applicable.
  • Adhere to company, quality, and safety standards, policies, and procedures.
  • Perform other duties as assigned.

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

QUALIFICATIONS

  • Bachelor of Science degree, preferably in biomedical, mechanical, or materials engineering.
  • A minimum of 10 years of experience in a medical device environment, with catheter experience preferred, or a combination of education and relevant work experience.
  • Proficiency in using computer systems for data analysis, particularly Microsoft Office.
  • Exceptional verbal communication, organizational, and management skills.
  • Training or equivalent experience in software applications including Microsoft Word, Excel, PowerPoint, and Access; Minitab experience is desirable.
  • Ability to implement quality programs, interpret collected data, and present findings to management to drive continuous improvement.
  • Strong analytical skills and the ability to process information effectively; promote process improvement, develop standards, manage processes, and support innovation.

COMPENSATION

The compensation range for this position is $125,000-187,000. The starting base pay for the successful candidate will be determined based on job-related skills, experience, qualifications, work location, and market conditions.

WORK ENVIRONMENT

This position is not remote. Work is conducted in an office environment with a moderate noise level. The characteristics of the work environment described here are representative of those an individual may encounter while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity 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 fully endorses equal opportunity for all and provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.