Post Market Quality Engineer I
San Jose, CR
hace 2 días
source : DirectEmployers Association

DescriptionPrincipal Responsibilities+ Responsible for timely handling of complaint and product quality issues, including submission and reporting of adverse events+ Responsible for assisting with Quality Holds+ Responsible for organizing and scheduling teams to facilitate complaint handling and field actions+ Responsible for coordinating communication with MicroPort global customers and the sales field as required for complaint handling and field actions.

  • Responsible for gathering, documenting, and recordkeeping of critical information related to complaints and / or field actions+ Responsible for accurate input of information into monthly reports, graphs, meeting minutes, etc.
  • and for timely distribution of such information.+ Responsible for reviewing complaint or field action records for completeness and contacting customers, patients, and the field for additional information.

  • Responsible for accurate, timely, and proper record keeping and closure of complaint and / or field action related files+ Responsible for accurate and timely handling of complaints and / or field actions+ Responsible for the identification and tracking of deadlines required throughout the department.
  • Conduct the investigation, resolution, and closure of product complaints promptly while facilitating efforts between Post Market Quality, Product Development, Quality Engineering, and Operations.
  • Initiate Corrective and Preventive Actions for product improvements. Participate in such teams.+ Communicate with all groups within the organization to gather information about product complaints, including product development, marketing, clinical, and the sales force.
  • Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required of the employee for this job.

    Duties, responsibilities, and activities may change at any time with or without notice.AccountabilityThis position is accountable for the evidence required to meet regulations.

    Failure to gather and maintain evidence of completion of any actions taken regarding adverse events reporting could result in the issuance of an FDA's Form 483.

  • The incumbent will be required to customarily and regularly exercise discretion and independent judgment. Failure will result in unnecessary Company expenses and may result in inaction on the non-conforming product.
  • With management support, ensure that company adverse events reporting and all related activities are timely filed following all appropriate regulations.
  • Responsible for ensuring all data and information supplied is both truthful and accurate.Skills Requirements+ Energetic, detailed oriented.
  • Strong organizational skills and the ability to interact with peers, medical professionals, consultants, and regulatory agencies are required.
  • The ability to organize and efficiently maintain / update documentation and databases is mandatory.+ Computer and strong written skills are required.
  • Ability to follow corporate procedures and management guidance.+ Ability to read, analyze, and interpret regulations and guidance documents related to product compliance topics focusing on the adverse events reporting process.
  • Ability to timely respond to inquiries from internal / external customers.+ Ability to effectively train other employees.
  • Documented evidence of proficient writing skills.+ Knowledge of : medical device regulations (FDA, ISO, etc.); design controls, risk management including FMEA (Failure Modes and Effects Analysis);
  • problem-solving techniques including root cause analysis; cause and effect analysis; interpretation and development of engineering specifications (including GD&T);
  • quality improvement; complaint investigation and resolution.+ Ability to analyze complex problems and apply practical solutions+ Ability to prioritize multiple projects and assignments consisting of varying degrees of complexity+ Ability to implement and use quality tools to meet departmental goals and objectives+ Working knowledge of Microsoft Office products (Word, Excel, Access, PowerPoint, and Project)Experience Requirements + Minimum of 1 year of experience required in medical devices or related field (Level 1)Education Requirements+ Education Required : Bachelor's Degree in a technical field required (Engineering degree preferred).

  • Education Preferred : Master's Degree in a technical field preferred (Engineering degree preferred. All candidates : Please fill out the online application and attach a resume that includes your current role, experience, education, and contact information.
  • Search Firm Representatives Please Read Carefully : MicroPort Orthopedics. is not accepting unsolicited assistance from search firms for this employment opportunity.

    Please, no phone calls or emails. All resumes submitted by search firms to any employee at MicroPort via email, the Internet, or in any form and / or method without a valid written search agreement in place for this position will be deemed the sole property of MicroPort.

    No fee will be paid in the event the candidate is hired by MicroPort as a result of the referral or through other means.

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