• Perform quality audits of suppliers as requested by management and/or corporate entities. Must use both technical and quality knowledge for supplier audit. The audit may be part of the supplier selection, qualification, and approval process. Perform corporate supplier audits either alone or as part of a team. May be the lead auditor or a team member. Requests support of SME if required.
• Responsible for assisting with the corporate Quality System by ensuring that the supplier audit program is implemented in compliance with existing procedural requirements. This may include audit scheduling and execution, complete timely audit reports, and may assist corporate entities with follow-up or review of SCAR input. Provide guidance regarding audit strategies and approaches.
• Provide supplier audit metrics which may be used in support of Management Review.
• Performs audits of ARDX/Alere corporate entities if requested in support of the corporate audit program. Audits must be documented in accordance with corporate standards in a timely manner. Audit metrics will be provided as required upon request.
• Carries out duties in compliance with established business policies.
• Demonstrates commitment to the development, implementation and effectiveness of ARDX/Alere Quality Management System per ISO, FDA, and other regulatory agencies.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Perform other duties & projects as assigned.
• Carries out duties in compliance with established business policies.
• Demonstrates commitment to the development, implementation and effectiveness of ARDX/Alere Quality Management System per ISO, FDA, and other regulatory agencies.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
• Perform other duties and projects as assigned.
• DIMENSIONS

EDUCATION / EXPERIENCE

Preferred educational background:

• BS/BA degree in Biological/Life Sciences, Engineering or related field.

Preferred experiential background:

• Minimum of ten years of experience in a medical device area with exposure to quality and manufacturing processes. Has an in-depth understanding of manufacturing processes and materials.
• Minimum of five years of medical device industry experience with strong working knowledge of quality audits, both internal and supplier, 21 CFR 820, part 803, part 806, part 11; and ISO 13485/GMP’s; and other international standards.
• ASQ Certification (CQA, CQE) or equivalent; specific work experience in quality auditing may be substituted for certificate.
• Ability to travel approximately 40-50 % of time for audits. A majority of travel will be domestic but ability to obtain a passport for international travel is required.
• Must have a valid driver’s license and be able to rent cars from commercial car rental agencies.
• Requires strong analytical, written and verbal communication skills and the ability to interface with persons of a variety of backgrounds.
• Must have good computer software skills with word processing, database management and spreadsheets.
• Experience with Root Cause Analysis a plus.
• Excellent verbal communication skills appropriate for acting as a liaison between ARDX/Alere and its suppliers. Must be able to make accurate assessments with limited time during an audit. Must be able to determine important data to obtain and not be afraid to request it. Must exhibit self-confidence and make on the spot decisions.
• Strong writing skills, including composition and grammar, in order to draft effective supplier and corporate audit reports.
• Effective organizational and time management skills.
• Characteristics which enable the individual to succeed are the following: organization, proactive approach, and data driven decision making.
• Must be proficient in use of personal computer and business/technical software (e.g., Microsoft Office).
• Must have capability to review, analyze, summarize and interpret quality systems data, draw conclusions, make appropriate decisions and recommendations, write reports and give oral presentations.
• Must show self-initiative but be comfortable in the role of a team player. Must be able to work independently with minimal supervision.
• Understands and is able to apply knowledge of the Quality Systems Regulations and international quality systems and medical device standards

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