Senior Quality Engineer – Healthcare company

Job Function Summary:

Responsible for providing leadership, managing, planning, executing and reporting on regulated Quality Assurance activities for internal/external audits. This individual is responsible for performing Internal, domestic and international audits(as appropriate) that ensure compliance with the FDA QSR, ISO, MDD, CMDR requirements, and other worldwide health authority regulations/guidelines, site SOPs, protocols, and industry standards, as applicable. The Auditor acts as a compliance resource and provides recommendations for corrective action and tracks corrective action commitments until closure.

Job Functions: (Primary “essential” duties and responsibilities)

  • Independently plans, conducts, and documents internal and external audits to assess compliance with the applicable standards and regulations and company SOPs.
  • Plans, executes and prepares clear and concise written reports of audit or review observations, including an assessment of compliance during internal audits of facility quality systems.
  • Supports Quality management, which includes ensuring that corrective and preventive actions are issued as required, properly investigated, documented, effective, and completed on time, and that audits are properly performed, documented, and completed in accordance with the annual audit procedure/schedule.
  • Facilitates and consults with corrective action teams in implementing changes to ensure compliance with all applicable QSR/ISO//MDD/CMDR and other applicable requirements.
  • Performs re-audits and/or effectiveness verifications as a way of assessing and documenting CAPA Effectiveness
  • Issues to management timely written audit reports and follows up on audit activities to ensure appropriate corrective action.
  • Escalates audit findings to the appropriate level of management.
  • Assists during third party audits.
  • This is not an inclusive list of job responsibilities.

Required Skills and Abilities:

  • Bachelor’s degree in Engineering or in a scientific or health-related field or equivalent is required.
  • Two years minimum ISO 13485 Lead Auditor is required.
  • ASQ -CQA (Certified Quality Auditor) is preferred.
  • Ability to prioritize and multi-task successfully in a fast paced environment
  • Ability to work both independently and in a collaborative team setting.

Experience and Education Requirements:

  • Minimum of eight years Quality Auditing experience conducting and participating in the Medical Device industry is required.
  • CQA Certification is preferred. Prior experience in a FDA regulated industry and/or ISO certified organization. Must have strong compliance background in 21 CFR 820, 801, 803, 806 as well as ISO13485, MDD, CMDR, ISO 14971.
  • Working knowledge of Quality Systems is required. Familiar with analytical software applications is preferred.
  • Project management and leadership experience is required.   Must demonstrate effective influencing and change management skills and demonstrated achievements in process improvements.
  • Must have strong verbal and written communication skills and demonstrate ability to be able to interact with all levels of an organization for the purposes of gathering data and feedback for investigations.
  • Must have the ability to understand procedural documents and evaluate these documents to ensure compliance to all applicable regulations and requirements.
  • Must possess strong organizational skills and demonstrate the ability to work independently.
  • Ability to use Microsoft Office Products such as Word , Excel, Power Point or equivalent software applications
  • May require up to 20% travel both domestic and internationally.

Quality Requirements:

  • Build Quality into all aspects of work.
  • Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to your job function).
  • Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
  • Attend all required Quality & Compliance training at the specified interval.
  • Adopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements.
  • Must practice verbatim compliance (exact compliance, no interpretation) with corporate Quality and Regulatory procedures (As applicable to your job function).
  • If your job description requires customer facing activities, you must thoroughly understand and comply with the Customer complaint reporting process and complaint procedures (As applicable to your job function).
  • Must be able to promptly report any non-compliance issues to Compliance officer or appropriate administrator, including the Compliance Hotline.
  • Must be competent with 21 CFR 820, 801, 803, 806 and any other applicable federal regulations, and Quality standards (As applicable to your job function).
  • Must not be debarred by FDA for work in any Medical Device or Pharmaceutical business.

Environmental/Safety Responsibilities:

  • Responsible for understanding and conforming with the Environmental Policy to ensure that significant environmental aspects that relate to actual or potential impacts with their work are executed to minimized the effects on the environment.
  • Responsible for bringing to the attention of management any potential improvements that could reduce our environmental impact or to report activities that could result in a negative impact to the environment.
  • Responsible for understanding and conforming with the Health and Safety Policy to ensure that the significant risks that relate to actual or potential hazards with their work are identified.

Disclaimer: The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.
Please submit resume to Michelle Carenza at

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