Regulatory Compliance Auditor in Bothell, WA at Volt

Job Description

VOLT is seeking candidates for "Regulatory Compliance Auditor" role for our client in Bothell, WA. This is a Direct Hire role. 

Candidate needs to work from Bothell, WA location. Some relocation assistance will be provided.

MUST HAVEs:

Internal and External Audit Experience

Medical Device Industry experience

Experience with MDSAP Audits

Job Description:

• Support the performance of internal audits to determine compliance with Quality Management System standards, policies, and procedures, as well as regulatory and customer requirements.
• Conduct and/or oversee and assist in conducting audits, generating reports, recommending corrective action plans, and verifying implementation effectiveness of QMS corrective and preventive actions for both internal, distributor, and software vendor audits.
• Prepare and/or lead regulatory assessments following established procedures; and prepare appropriate reports of audit findings to audited parties and management representatives.
• Execute to the Internal Audit schedule, Distributor Audit Schedule, and Software Vendor Audit Schedule.  Support audits, monitor execution, and ensure timely completion of observation response and action items.
• Support Director in developing auditor-training programs for internal, supplier, and external audit management.
• Support Director in the execution and distribution of standard metric reports, preparation of compliance input for management reviews, maintain company compliance scorecard, and related documentation.
• Maintain configuration of electronic Quality Management Software (eQMS) Audit module.
• Provide support in the management, Regulatory Authority reporting, and tracking of Field Corrective Actions.
• This role will require the ability to work autonomously on specific compliance activities including projects and based business tasks, both planned and unplanned with accelerated timelines; other duties as assigned.

Knowledge, Skills, and Abilities:

• Bachelor’s Degree in a Scientific or Engineering field required.
• A minimum of 5 years’ experience in compliance and/or quality system activities in a QSR/13485 Quality Management System and MDSAP audits.
• Knowledge of the following regulatory requirements is required: GMPs, MDD / MDR, CMDR, TGA, ANVISA, PMDA.
• Proven track record of successfully supporting external audits (such as FDA, Notified Body, or customer audits) required. Front and backroom support preferred.
• Demonstrated knowledge, understanding or application of audit principles, concepts and practices related to a regulated quality system.  Able to collaborate effectively with employees of various disciplines and departments.
• The ability to complete regulatory reports and provide written correspondence to internal and external customers including regulatory bodies. 
• Must have the ability to handle confidential data.
• Lead Auditor or ASQ Certification (e.g. Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), etc.) or equivalent work experience required.
• Must be a critical thinker, detailed oriented with strong problem-solving skills, able to oversee multiple tasks for several projects or base business deliverables, and effectively balance priorities.

VOLT is an Equal Opportunity Employer