Sr. Quality Assurance Specialist

Current•Menlo Park, CA

About The Position

RESPONSIBILITIES: Complaint Handling Own and lead complaint initiation, investigation, and closure in compliance with regulatory requirements and internal procedures. Perform root cause analyses and risk assessments to determine reportability, escalation, and corrective actions. Trend and analyze complaint data to identify systemic issues and improvement opportunities. Nonconforming Material Partner with Manufacturing and Engineering to resolve nonconformances and prevent recurrence. Own Nonconforming Material Reports (NCMRs), including investigation, risk assessment, disposition decisions, and closure. Lot History Review Perform and approve Lot History Record (LHR) reviews to support product release and investigations. CAPA Escalate problems for possible corrective actions to manager. Assist with CAPA investigations, root cause analysis, action planning, and effectiveness verification. Ensure CAPA activities are timely and compliant with internal procedures. Document Control & Training Review and release Engineering Change Orders (ECOs) into eQMS ensuring accuracy, traceability, and compliance. Review controlled documents for compliance, clarity, and consistency. Oversee training assignment and completion, assess training effectiveness and compliance. Supplier Quality Assist with supplier qualification activities, including risk assessments, and documentation review. Support supplier audits and corrective action activities. Audits Serve as a QA SME during internal and external audits. Ensure timely and effective closure of audit observations and nonconformances. Carry out all duties and responsibilities as assigned by the Company in accordance with Company policies, procedures, and applicable laws and regulations governing our business practices.

Requirements

Four-year college degree or equivalent combination of education and experience
5+ or more years’ experience in a quality environment with an understanding of quality systems and processes
Demonstrated experience leading complaint investigations and NCMRs
Demonstrated experience reviewing and releasing approved ECOs into eQ
Demonstrated experience assisting in CAPA investigations, audits, and supplier qualification
Strong working knowledge of FDA 21 CFR 820, ISO 13485, and risk management principles
Good verbal and written communication and interpersonal skills
Strong root cause analysis and problem-solving skills.
General proficiency in basic computer skills, including MS Office software suite, experience in quality management system software databases
Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors
Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
Detail oriented with a focus on compliance with both internal and external requirements and an understanding of good manufacturing practices

Nice To Haves

Medical device experience or equivalent experience in a related field preferred

Responsibilities

Complaint Handling Own and lead complaint initiation, investigation, and closure in compliance with regulatory requirements and internal procedures.
Perform root cause analyses and risk assessments to determine reportability, escalation, and corrective actions.
Trend and analyze complaint data to identify systemic issues and improvement opportunities.
Nonconforming Material Partner with Manufacturing and Engineering to resolve nonconformances and prevent recurrence.
Own Nonconforming Material Reports (NCMRs), including investigation, risk assessment, disposition decisions, and closure.
Lot History Review Perform and approve Lot History Record (LHR) reviews to support product release and investigations.
CAPA Escalate problems for possible corrective actions to manager.
Assist with CAPA investigations, root cause analysis, action planning, and effectiveness verification.
Ensure CAPA activities are timely and compliant with internal procedures.
Document Control & Training Review and release Engineering Change Orders (ECOs) into eQMS ensuring accuracy, traceability, and compliance.
Review controlled documents for compliance, clarity, and consistency.
Oversee training assignment and completion, assess training effectiveness and compliance.
Supplier Quality Assist with supplier qualification activities, including risk assessments, and documentation review.
Support supplier audits and corrective action activities.
Audits Serve as a QA SME during internal and external audits.
Ensure timely and effective closure of audit observations and nonconformances.
Carry out all duties and responsibilities as assigned by the Company in accordance with Company policies, procedures, and applicable laws and regulations governing our business practices.