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Sr. Quality Specialist

February 23 2017
Industries Healthcare, social assistance
Categories Operations (manufacturing, packaging), Quality assurance and control - Validation
Richmond, BC

At Boston Scientific, our products and technologies are used to diagnose or treat a wide range of medical conditions. In Interventional Cardiology (IC) we design, develop, and produce technologies for diagnosing and treating coronary artery disease and other cardiovascular disorders. Medical conditions we provide solutions for include: cardiovascular diseases, coronary artery disease, acute myocardial infarction. We are able to provide a numberof solutions to patients that include: drug-eluting stents, bare-metal stents, catheters, balloons, guide wires, coronary atherectomy and coronary intravascular ultrasound.

Purpose Statement

Provide and lead quality assurance oversight for the Operations Group to ensure compliance with all applicable regulations including documentation reviews, discrepancy system management, audit support, technical, projects, and documentation.

Key Responsibilities

  • Facilitate development and maintainence of the quality management system according to ISO, MDD and FDA requirements.
  • Maintain the CAPA system to ensure  proper notification, impact assessment, root cause analysis, investigations and effectiveness verifications to ensure all requirements are met.
  • Perform complaint handling, including root cause analysis, investigations, corrective action determinations, and as appropriate, adverse event determinations and reporting
  • Provide system administration duties and technical interface with consultants to support and maintain the Manufacturing Pro database, including software changes and re-validation acitivities.
  • Perform audits/assessments internally and of suppliers for compliance to quality system and regulatory requirements.  Support internal and external audits as well as follow through on audit responses.
  • Maintain the PIR process, including compliance to procedures, timelines, and reporting to BSC
  • Lead special projects that require Quality Assurance expertise including improvements to quality systems.
  • Perform trending of data and quality systems as relates to annual reporting, management metrics and other trending, as required.

Quality System Requirements

In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Basic Qualifications

Bachelor's and 6+ years of relevant industry experience with experience in the medical device industry

Preferred Qualifications

•ASQ (or similar) certification preferred

•Excellent interpersonal skills

•Strong presentation skills and MS Office skills

•Experience with major systems (e.g. eCAPA, PDM, CRD, SAP, VIP, Clarizen) desirable

•Strong analytical and investigation skills

•Demonstrated leadership ability

Boston Scientific (NYSE: BSX) transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 30 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare.

Boston Scientific is an Equal Opportunity Employer. network