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Staff I, Engineer, Quality SystemsApply Now Job ID R-17240 Date posted 08/11/2017
Job Description SummaryAs directed by the Associate Quality Director, the Staff Quality Engineer I is accountable for support in the continued development, improvement, and expansion of the Diabetes Care WW Quality Management System as well as maintaining compliance with regulations, standards, and Corporate requirements. This position provides collaborative support to quality system leadership and may work with other functions within the organization including Operations, Quality, R&D, Procurement, Marketing, Regulatory and Medical in addition to corporate functions, regulatory agencies and suppliers.
- Coordinate quality systems and processes to ensure compliance with Quality System and regulatory requirements and promote quality improvements.
- Develop and make updates to applicable Site / Unit procedures and policies
- Provide a quality review on a range of quality documentation including Unit Policies, Procedures, Investigations, Change Controls, GMP records and other Quality Management Systems Documentation as required.
- Lead unit-level quality system processes and systems (SAP, TrackWise, ECC, DMS, etc) for CAPA, audit, Quality notification, calibration, supplier management, document and change control.
- Ensure investigations are conducted and adequately resolved in a timely manner with appropriate CAPAs in place to prevent reoccurrence of issues.
- Conducts or leads internal audits and supplier audits.
Experience and Education:
- A minimum of 8 years relevant experience or a combination of higher education and relevant experience.
- Bachelor’s Degree. MS preferred.
- Certified Quality Engineer and Certified Quality Auditor (preferred).
Knowledge, Skills and Abilities:
- Strong knowledge of 21CFR820/210/211/11, ISO 9001, ISO 13485 and other applicable medical device regulations.
- Understanding of continuous improvement methodologies including Lean, Six Sigma, SPC, etc. is desired.
- Ability to support internal / external audits.
- Excellent communication, problem solving, organizational and interpersonal skills are essential.
- Full proficiency in Microsoft Office required
- Self-motivated and directed, requiring minimal supervision
- Demonstrated ability to work in teams to obtain results is required.
- Effective skills in analytical thinking and problem solving required.