At Abbott, a global healthcare leader, the business problem is to ensure the quality of supplied products and maintain compliance with regulatory requirements, such as FDA regulations, to provide life-changing technologies to people in more than 160 countries.
Requirements
- Bachelors Degree in Technical Field or Equivalent combination of education and work experience
- 2 years of related work experience
- Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
- Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
- Medical device experience
- Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
- ASQ CQE or other certifications
Responsibilities
- Contributes to the development, maintenance and improvement of division supplier development quality program policies, procedures and forms.
- May provide coaching, and mentoring for technical team personnel.
- Provides guidance and training to Purchasing, R&D, Manufacturing and Quality engineers in applying program requirements.
- Reviews and approves all supplied product drawings and component quality plans.
- Manages development of supplied product inspection procedures and first article requirements.
- Provides engineering guidance to division Receiving Inspection including statistical analysis, measurement techniques, Gage R&R studies and inspection procedures.
- Assesses supplier capabilities through direct visits, technical discussions, directed testing and quality system audits.
Other
- Bachelors Degree in Technical Field or Equivalent combination of education and work experience
- 2 years of related work experience
- Travel: Yes, 5 % of the Time
- Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
- Keyboard use (greater or equal to 50% of the workday)
