Staff I Engineer, Quality Systems - United States
- 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.