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Sr. Quality Engineer

3 months ago

Aurora, United States Actalent Full time
Description:
Sr. Quality Engineer
Will assume responsibility of local Quality Management System (QMS) management. The position will manage the key elements of QMS processes as assigned, which may include CAPA, nonconformance, internal & external audits, KPI metrics, document and training management, and local Quality management review.
•Run the local CAPA and NC program.
•Act as the project manager for the CAPA and NC events to ensure successful and timely completion from the initiation phase to CRB approval.
•Hold regular meetings with all the stakeholders to document and track the CAPA and NC activities.
•May require supporting QMS document management, change control, training, and Quality Management Review related activities as needed.
•Coordinate Risk Management activities (pFMEA, etc.)
•Work with in-house ERP, CRM, DMS systems and other databases
•Use risk approach for decision-making.
Additional Skills & Qualifications:
BS in an Engineering, Science, or related field required
Experience to manage quality management system in a medical device company for 2+ years.
Strong collaboration experience
Good project management skills: capable of effectively managing multiple projects and objectives concurrently
Strong interpersonal and leadership skills, particularly across functions
Solid understanding of medical device manufacturing and regulations (ISO 13485, FDA QSR)
Strong analytical skills; technical and conceptual attitude
Proficient at data analysis in ERP, CRM, DMS and other Database.
Position requires work in both office and manufacturing environment
NICE TO HAVE
-ASQ Certification (CQE, CQM, CSSBB, CQA, or other) desired
-Certification in internal audit for ISO 13485, ISO 9001 desired
-Knowledge of statistics and analytical problem-solving tools is a strong plus
-Minitab experience is a plus
-Electronics, acoustics, and / or industrial engineering knowledge is a plus
About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
  • Hiring diverse talent
  • Maintaining an inclusive environment through persistent self-reflection
  • Building a culture of care, engagement, and recognition with clear outcomes
  • Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.