ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Willingness to be proactive, work independently, and as a contributing member of an audit team
- Assist in the creation and planning of the internal and external audit schedule.
- Conduct supplier and internal system audits to meet established audit schedule.
- Conduct quality system audits at other Joerns facilities
- Generate audit reports and participate in trend analysis to identify and help rectify repeat audit findings
- Facilitate effective corrective/preventive actions. Ensure audit nonconformances are addressed in a timely manner, and facilitate effective and timely communication of audit results, trending, and data mining.
- Through risk analysis assist with the determination of supplier assessment requirements based on component/product risk profile.
- Coordinate the approved vendor listing (AVL). Approve/disapprove suppliers.
- Works closely with the product development group in the generation of control documents such as Quality Plans, FMEAs, Design Verification and Validation Plans.
QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
§ BS/BA plus a minimum of 3-5 years experience in a medical device or regulated industry conducting internal audits and /or external audits
§ Must be willing to travel up to 30% of the time
§ Must possess Good Communication skills communication skills, tact and diplomacy
§ ISO certified auditor or lead auditor or ASQ Certified Quality Auditor (CQA).
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to apply mathematical and analytical skills to quantify results.
Joerns Healthcare Inc. is an Equal Opportunity / Affirmative Action employer. All candidates are selected solely on the basis of legally permissible job related criteria
Joerns Healthcare Inc. - 24 months ago