Address
Form of work
SalaryConduct internal audits to ensure the quality system conforms to documented arrangements and regulatory requirements and that is effectively implemented and maintained.
Key Responsibilities :
Prepare the audit plan, to ensure coverage of applicable regulations, processes, and elements according to the audit schedule.
Conduct audits including complex assessments, to ensure conformance with applicable regulations and EW procedures and instruction. Assess objective evidence to determine conformity to requirements listed above, including ranking the levels of nonconformance findings
Assess previous audit findings to establish strategies and evaluate the effectiveness of the actions taken.
Conduct opening meetings and closure meetings.
Prepare audit documentation including attendance sheets, audit plan and audit report. Ensure documentation is complete, including all objective evidence.
Execute audit considering scope to assure efficient and effective use of scheduled time allocations
Assist in generating metrics for overall auditing system and identify continuous improvement opportunities; may also present metrics to all level of the organization
Other duties assigned by Leadership
Minimum Required Qualifications:
Bachelor’s Degree with 5 years of quality compliance auditing experience; or Master’s Degree with 3 years of quality compliance auditing experience
ISO 13485 Certified Lead Auditor
Medical device and/or pharmaceutical industry experience
Experience preparing, conducting, and documenting internal audits
In-depth knowledge and working experience with medical device regulations: 21 CFR Part 820, SOR/98/282, RDC 16, MHLW 169, TG 2002, MDSAP, and/or EU MDR 2017/745
Excellent written and verbal communication skills including negotiating and relationship management skills
Strong problem-solving and critical thinking skills
Preferred Qualifications :
Experience with Quality Systems (i.e. CAPAs, NCRs, Field Corrective Actions, etc)
Ability to manage multiple concurrent audits
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California, the base pay range for this position is $76,000 to $108,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).
