Quality Systems Specialist

Tasks and Responsibilities

• Supports all aspects of the internal audit program, ISO notified body audits, customer audits and FDA inspections, including but not limited to:
  • Serve as an auditor for internal audits
  • Create and maintain internal audit schedule
  • Audit controlled document files in preparation for regulatory inspections and provides support during regulatory inspections and client audits
  • Initiate and execute audits, including developing and documenting the audit plan, leading the audit, generating the audit report, and tracking subsequent actions with the team
  • Provide support during external audits including scheduling, hosting, preparing audit responses
  • Work with subject matter experts to ensure audit record content is accurate, well documented, and meets the requirement of the process
• Develops metrics and performs trend analysis of key QS areas such internal and

 external audit findings, CAPAs, nonconforming material, training, deviations, etc. to identify areas for improvement. Escalates trends to an appropriate quality system such as CAPA or CI; presents analysis to management

• Supports maintenance of the CAPA program
  • Serves as CAPA Owner as needed, driving necessary investigation, correction, and corrective/preventive actions
  • Ensures all internal and external audit findings are entered into the CAPA system, assigned to the appropriate personnel, and are completed in accordance to the CAPA procedures, within specified time periods
  • Approve corrective action plans and verify effective and timely implementation of corrective actions for audit nonconformities
• Oversees completion and control of customer questionnaires and other customer-required documents
• Initiates, facilitates and/or manages projects to expand, change, enhance and improve the quality system, as assigned
• Supports and coordinates activities related to nonconforming material, complaint/customer feedback, deviations, RMA, and CAPA processes
• Provides quality system training for the organization as needed
• Manages review of documents to ensure ISO/FDA compliance of controlled documents lifecycle including annual review management
• Ensures all work is performed and documented in accordance with GMP requirements and existing company policies and procedures
• Other duties as assigned

Education and Experience

Required

• Minimum of 2 year degree in Quality, Regulatory, Manufacturing or related field; OR certificate in Regulatory Science or Medical Product Development plus 1 year of regulated industry work experience

Desired

• 4 year degree in Quality, Regulatory, Manufacturing or related field
• ISO13485:2016 and/or ISO9001:2015 Auditor Certification

• Knowledge and experience with GMP/ISO Standards: ISO 9000/9001, ISO 13485, and FDA 21CFR 820/11 (4/210/211 as applicable)
• 3 years of quality/regulatory experience in medical device or related industry
• 1 year experience conducting investigations and root cause analysis for complex/advanced issues

Competencies

• Ability to read, write, speak and understand the English language
• Ability to communicate clearly by conveying and receiving ideas, information and direction effectively
• Ability to demonstrate adequate job knowledge to deliver a world class performance
• Ability to challenge oneself to consistently meet all goals and deadlines
• Willingness to strive for excellence by producing work that is free of errors and mistakes
• Desire to delight both customers and coworkers by offering encouragement, fostering teamwork and addressing conflict appropriately
• Commitment to making improvements company wide
• Demonstrated competence using Microsoft Office
• Comprehensive understanding of applicable cGMP requirements, including ISO standards, and FDA and other QS regulations
• Comprehensive understanding of internal documentation (e.g., QS Manual, SOPs, etc.) and records and how they relate to cGMP requirements
• Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques
• Experience with metrics development and data analysis
• Able to provide compliance guidance based on knowledge of regulations, available relevant information, alternatives, and risk
• Able to perform math functions
• Effective trainer and project leader
• Good hand/eye coordination and depth perception
• Good manual dexterity
• Ability to maintain a professional and respectful relationship with coworkers and company representatives

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran, disability, or any other status protected by state or federal law.

NOTE:  This job description is not intended to be all-inclusive. Employees may perform other related duties as required to meet the ongoing needs of the organization.

Salary : $68,000 - $76,000