Advanced Quality Assurance Specialist - Supplier Management

Role Summary

The Advanced Quality Assurance Specialist will work closely with internal colleagues as a key member of the Quality Assurance team working to maintain and grow Asuragen’s Quality Management System in alignment with international quality and regulatory standards.

Responsibilities

• Provides support ensuring compliance with all regulatory standards, systems, procedures, and practices. Includes ISO 13485, FDA QSR, MDSAP, IVDR, and other requirements relating to Quality Assurance activities.
• Manages supplier quality from the perspective of supplier adds, removals, validation, qualification, classification, audits, and evaluation.
• Assists in internal and external audits and resultant findings resolutions
• Assists in the execution of Document Control, Training, NCR, CAPA, Complaints and OOS systems. May be responsible for the management of one or more of these systems.
• Reviews and approves quality equipment calibrations and maintenance.
• Supports the overall Quality goals and QA Department goals.
• Generates metrics in support of Quality Management Reviews.
• Other duties as assigned.

Qualifications

• Bachelors/Masters degree in a related field from an accredited four-year college or university, 4-6 years of experience in a regulated manufacturing facility; or a combination of educational and applicable work experience.

Skills

• Skilled in the use of software programs such as Microsoft Office and database management programs.
• Detail oriented and skilled at examining documents for accuracy and completeness. Ability to prepare records in accordance with detailed instructions.
• Knowledgeable in QA principles and concepts in a dynamic manufacturing facility
• Ability to set priorities and meet deadlines on a personal level. Ability to work under tight deadlines.
• Capability to effectively train employees on procedures, processes, and QA concepts.
• Team oriented individual with the ability to work effectively with multiple skill level employees. Skilled at dispute resolution.
• Excellent written and oral communication skills.
• Excellent analytical and problem-solving skills with the ability to work independently with minimal supervision.
• Familiarity with statistical tools and concepts and their application in a regulated environment.
• Knowledge of cGMP, ISO 13485, MDSAP, IVDD/IVDR and FDA QSR preferred.

Education

• Bachelors/Masters degree in a related field from an accredited four-year college or university.