Sr. Supplier Quality Engineer - Mahwah, NJ in Mahwah, NJ at Getinge

Date Posted: 7/24/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Mahwah, NJ
  • Experience:
    Not Specified
  • Date Posted:
    7/24/2019

Job Description

Position Overview:

Responsible for providing leadership, technical support while planning, executing and reporting on internal or external audits for quality assurance. Provides training in audit techniques and ISO, QSR and MDD requirements, facilitating and consulting with corrective action teams in implementing change.

Job Duties:

  • 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.
  • Plans, executes and reports on internal audits of facility quality systems.
  • Facilitates and consults with corrective action teams in implementing changes to ensure compliance with all applicable ISO/QSR/MDD requirements.
  • Trains internal auditors in auditing procedures and practices.
  • Performs re-audits and/or effectiveness checks 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 the Director and Manager of Quality Assurance during third party audits.
  • Participates on technical and operational teams.
  • Delegation:  Approves other’s audit reports in the QA Manager’s absence.
  • Must be a compliance expert in 21 CFR 820, 801, 803, 806 as well as ISO13485, ISO 14971.
  • Supports Supplier management, which includes maintaining supplier corrective actions, supplier audits, supplier certification, non-conforming material review and supporting incoming material inspection.
  • Coordinates and completes all tasks and documentation required for externally supplied component qualifications (First Article Inspections).
  • Identifies new opportunities for improvements to work processes.
  • This is not an inclusive list of job responsibilities.

Background Experience:

  • Bachelor's degree in Engineering, Science or related field or equivalent work experience and appropriate certifications.. A Masters of Science in Engineering, Science or related field is preferred. CQE (Certified Quality Engineer) or CQA (Certified Quality Auditor) is preferred.
  • A minimum of 5years’ experience conducting and participating in FDA/customer/corporate audits.
  • Minimum of 5 years experience in Quality Assurance, Quality Engineer or related function or an MS plus 3 years experience is required.  Prior experience in an FDA regulated industry or ISO certified organization.
  • Must have demonstrated proficiency in statistical analysis, the ability to analyze and solve complex problems, and the ability to communicate effectively across departments. 
  • 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.
  • A thorough understanding of effective quality systems and the demonstrated ability to influence and achieve quality process improvements.
  • Must possess strong organizational skills and demonstrate the ability to work independently.
  • Ability to use Microsoft Office Products such as Word , Excel or equivalent software applications
  • Requires 70% travel both domestic and internationally.

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.