Manager, Quality

4 weeks ago

San Jose, United States miraDry, Inc. Full time

Job Summary and Primary Responsibilities

Efficiently manage all aspects of Quality, including Quality Engineering, Quality Control, New Product Development Quality, Corrective & Preventive Actions, Temporary Deviations, Nonconforming Materials, Risk Management, Standards Management, Internal Audits, Document Control, Training, Complaint Handling, and Adverse Event reporting.


  • Comply with miraDry Inc’s quality system requirements as well as any applicable regulatory Requirements
  • Comply with all health and safety regulations, policies, and work practices
  • Recruit, hire, train, manage, and develop Quality staff members
  • Provide quality support to product development, manufacturing, and service activities
  • Make decisions related to product quality and release
  • Manage creation and approval of test protocols and reports, including design verification and validation, and packaging validation
  • Manage the Device Master Record (DMR) process
  • Manage quality software change controls and problem reporting
  • Assess current practices against external standards, regulations, and guidance documents
  • Coordinate and conduct quarterly Management Review meetings and monthly scorecard reviews
  • Manage Field updates, Field Actions, and Corrections and Removals
  • Actively communicate with external suppliers, regulatory agencies, distributors, departments, and sales representatives to ensure compliance with Complaint Handling and Field Action/Recall processes and timely complaint record closures.
  • Manage the field action process including initiation, customer and regulatory notification, and product withdrawal
  • Work with cross-functional team to coordinate required documentation of field actions (e.g., assessment forms, Health Hazard Evaluation documents, Correction and Removal documents, etc.)
  • Prepare customer letters, summary field action status reports, and communications to regulatory agencies and competent authorities for field actions
  • Perform internal and supplier quality audits
  • Prepare and present quality trend analyses for reporting through quality system processes, including Management Reviews, CAPA reviews, and Risk Management reviews.
  • Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products
  • Manage the end-to-end process for complaints, including Intake and assessments/decision trees, investigations and resolution, returned goods evaluations, review of manufacturing records, decontamination and inspection of samples, evaluations of raw materials, manufacturing processes and LHR review, and testing as appropriate.
  • Work with cross-functional team to create and release postmarket surveillance plans and reports
  • Complaint handling software (CATSWeb) owner
  • Actively communicate with external suppliers, regulatory agencies, distributors, departments, and sales representatives to ensure compliance with Complaint Handling Process and timely complaint record closures.
  • Follow current policies and procedures to ensure compliance with all US and international regulations relating to complaint reporting
  • Perform complaint database searches and provide complaint data input to annual reports, submissions, corrective actions or as requested for engineering sales/marketing, etc.
  • Perform other duties as assigned


Required Skills / Capabilities

  • Document training on the miraDry, Inc. quality system requirements as applicable
  • Demonstrate knowledge of ISO/EN ISO 13485, ISO/EN ISO 14971, MDD 93/42/EEC, EU MDR 2017/745, CMDR, US 21 CFR Parts 803, 806, and 802, Australian TGA Regulations, Brazil ANVISA Resolution – RDC 16, Japanese PMD Act requirements, SOR/98-282: Canadian Medical Devices Regulations (latest consolidated version).
  • Knowledge of US and international, medical device adverse event reporting requirements
  • Demonstrated ability to apply risk management techniques
  • Demonstrated knowledge of word processing and spreadsheet programs.
  • Requires creative, problem-solving ability
  • Team oriented, the ability to work in small team
  • Environment is essential; must also be a self-starter with the ability to work independently
  • Good planning and organization skills are vital. Strong critical thinking and problem-solving skills
  • Ability to manage multiple priorities
  • Effective verbal and written communication skills are essential.


Education and Experience

  • Requires a minimum of 5 years of related experience in the medical device industry, with a Bachelor’s degree; or 3 years related experience and a Master’s degree.
  • 3+ years experience in people management.
  • Experience with FDA Class II Medical Devices is required.


*Salary is dependent on experience

FLSA Status: Exempt

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