Boston Scientific
Quality Auditor II
The Quality Auditor II performs detailed audits of practices at company manufacturing plants and sites to ensure that policies and procedures comply with FDA, ISO, MDD and other relevant standards and regulations. Reports on weaknesses, ineffective procedures, policy exceptions and discrepancies. Consults with management to establish practices and procedures that comply with FDA regulations and applicable standards. Your responsibilities will include: Responsible for conducting and confirming follow-up actions on Corporate/Divisional/Site Compliance Audits. Responsible for working with management and/or teams on validations, protocol and process reviews, and implementation of requirements in compliance programs. Plan and conduct scheduled audits to assess compliance with FDA, ISO, MDD, and other external requirements. To include audit scheduling, investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions. Participate in planning, coordination, and implementation of corporate and site audit policies. To include review of updated GMP/QSR regulations and current FDA and non-US requirements (ISO) and incorporation into internal programs where appropriate. Review, understand, and implement changes related to ISO/GMP changes. Includes incorporation of this information into corporate and divisional programs through document reviews, protocol reviews, validation reviews, and training programs. Participation with Corporate and divisional QA on policy/procedure/guideline development. Includes generation, review, and implementation of these documents. Required Qualifications: Minimum of a Bachelors Degree Minimum of 2 years previous experience auditing to medical device Quality System regulations Previous experience developing audit plans and audit reports Ability to evaluate compliance to applicable external and internal regulations and requirements Preferred Qualifications: Education/Certification: Lead Auditor ISO 13485 Certification Education/Certification: ASQ Certified Quality Auditor (CQA) or Certified Medical Device Auditor (CMDA) Experience: Demonstrated lead auditor experience Comprehensive working knowledge, interpretation and application of all regulations and standards listed in the BSC Global Policy Quality System Management, including but not limited to: 21 CFR Part 820, ISO 13485, EU MDR 2017/745, AIMDD, MDD, MHLW Ordinance 169, MDR SOR/98-282, 21 CFR Part 211, ISO 14971, Therapeutic Goods Regulations 2002, Resolution RDC 16/2013, 21 CFR Part 4, as applicable to site Ability to lead others to achieve common goals and objectives, e.g., on specific internal audits Ability to demonstrate equanimity, effectiveness, and leadership in challenging situations Strong verbal / written communication, interpersonal and organizational skills Ability to communicate effectively with all levels of the organization Must be proactive and able to work independently with minimal supervision Ability to work effectively in a hybrid mode: work from home, work from site Requisition ID: 610371
The Quality Auditor II performs detailed audits of practices at company manufacturing plants and sites to ensure that policies and procedures comply with FDA, ISO, MDD and other relevant standards and regulations. Reports on weaknesses, ineffective procedures, policy exceptions and discrepancies. Consults with management to establish practices and procedures that comply with FDA regulations and applicable standards. Your responsibilities will include: Responsible for conducting and confirming follow-up actions on Corporate/Divisional/Site Compliance Audits. Responsible for working with management and/or teams on validations, protocol and process reviews, and implementation of requirements in compliance programs. Plan and conduct scheduled audits to assess compliance with FDA, ISO, MDD, and other external requirements. To include audit scheduling, investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions. Participate in planning, coordination, and implementation of corporate and site audit policies. To include review of updated GMP/QSR regulations and current FDA and non-US requirements (ISO) and incorporation into internal programs where appropriate. Review, understand, and implement changes related to ISO/GMP changes. Includes incorporation of this information into corporate and divisional programs through document reviews, protocol reviews, validation reviews, and training programs. Participation with Corporate and divisional QA on policy/procedure/guideline development. Includes generation, review, and implementation of these documents. Required Qualifications: Minimum of a Bachelors Degree Minimum of 2 years previous experience auditing to medical device Quality System regulations Previous experience developing audit plans and audit reports Ability to evaluate compliance to applicable external and internal regulations and requirements Preferred Qualifications: Education/Certification: Lead Auditor ISO 13485 Certification Education/Certification: ASQ Certified Quality Auditor (CQA) or Certified Medical Device Auditor (CMDA) Experience: Demonstrated lead auditor experience Comprehensive working knowledge, interpretation and application of all regulations and standards listed in the BSC Global Policy Quality System Management, including but not limited to: 21 CFR Part 820, ISO 13485, EU MDR 2017/745, AIMDD, MDD, MHLW Ordinance 169, MDR SOR/98-282, 21 CFR Part 211, ISO 14971, Therapeutic Goods Regulations 2002, Resolution RDC 16/2013, 21 CFR Part 4, as applicable to site Ability to lead others to achieve common goals and objectives, e.g., on specific internal audits Ability to demonstrate equanimity, effectiveness, and leadership in challenging situations Strong verbal / written communication, interpersonal and organizational skills Ability to communicate effectively with all levels of the organization Must be proactive and able to work independently with minimal supervision Ability to work effectively in a hybrid mode: work from home, work from site Requisition ID: 610371