Regulatory Audit Specialist Job

REGULATORY AUDIT SPECIALIST is needed for a CONTRACT position with Yoh's client located in WARSAW, IN 46580.

TOP SKILLS YOU SHOULD POSSESS:

- Medical Device Compliance Auditing Expertise

WHAT YOU'LL BE DOING:

- The primary job responsibility is auditing company Quality Systems and processes for compliance to the applicable internal company policies and procedures, the Quality System Regulation (21 CFR, Part 820), ISO 13485:2003, the Medical Device Directives (MDD), and all other applicable standards and regulations.
- Plan audits by preparing and communicating audit plans. Execute audits through the evaluation of operations/processes, the review of documents and records, and interviews of employees for compliance. Communicate audit results through the preparation and publication of audit reports.
- Follow-up audit results by seeking appropriate corrective actions if deficiencies are noted. Track implementation of corrective actions and verify actions for effectiveness.
- Support management on tracking audit activities and administration of internal audit schedule.
- Support external audits with regulatory agencies and registrars if necessary.
- Support Top Management in achieving Quality Systems objectives and any other regulatory objectives (eg, QSR training, Quality Systems initiatives, etc).

WHAT YOU NEED TO BRING TO THE TABLE:

- Bachelor's Degree in a technical discipline or an alternative Bachelor's degree program plus five (5) years experience in a Quality role § Computer knowledge on MS Office applications or equivalent.
- Minimum of five (5) years of auditing experience preferred
- Certification in a quality discipline (eg CQE, CQA, etc) preferred § Medical Devices regulations knowledge and experience preferred
- Must be familiar with all aspects and elements of a quality system including but not limited to CAPA, management responsibility, product realization and measurement, analysis and improvement processes.
- Must have basic knowledge of manufacturing processes and be willing to work towards in-depth understanding of company processes and products.
- A strong background in math, chemistry, engineering or microbiology is desirable to enable the individual to evaluate systems such as machining, sterilization, electrochemical processes, statistical process data, etc.
- Knowledge of Quality Systems Regulations or ISO requirements and guidelines. Understanding of JPAL, MDD, and CMDR requirements preferred.
- Must be reliable and capable of working with minimal supervision to manage audit planning and execution, and follow-up activities.
- Basic experience or knowledge on issue resolution disciplines (eg, problem solving/decision making, root cause analysis, etc).
- Must be able to manage stressful situations and to handle controversial issues.
- Highly compliance oriented to firmly adhere to the principles of the regulations and standards.

IF THIS SOUNDS LIKE YOU, APPLY NOW!

RECRUITER: James Dangler

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