Main Responsibilities
- Perform quality system and manufacturing process audits
- Prepare audit report that establishes the outcome of the audit and the detail of non-conformances identified during the audits
- Track audit results including corrective actions, and follow up to these actions as required
- Support Abbott Third party and regulatory agency inspection as required
- Provide support to SQA team as needed
Experience/Background:
- Related work experience with a strong understanding of audit process per ISO 13485 and FDA regulations for Medical Device
- A minimum of 6 years working in Medical Device Industry
- Good problem-solving skills and critical thinking
- Demonstrate excellent interpersonal skills when dealing with internal and external customers
- Demonstrate fact-based decision-making skill.
- Communicate effectively both written and oral modes
- Ability to work independently and effectively with other team members
Education/Certification:
- Bachelor Degree – prefer in Science or Engineering
- CQA (preferred)
This job description will be reviewed periodically and is subject to change by management.
NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law, including disability/veteran status. This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company’s facilities.