Quality Assurance Specialist

Job Scope

The Quality Assurance Specialist supports the administration, execution, maintenance, and continuous improvement of the Quality Management System to ensure compliance with applicable procedures, standards, and regulatory requirements. The role may support multiple Quality System processes based on business needs, experience, and assigned areas of responsibility, and works cross-functionally to promote effective, compliant, and sustainable Quality processes.

Job Responsibilities

• Support the administration, maintenance, and continuous improvement of the Quality Management System to ensure compliance with applicable procedures, standards, and regulatory requirements.
• Perform assigned Quality System activities, which may include document and records management, change management, product or batch record review and release, training administration, electronic Quality Management System administration, calibration, supplier qualification/re-qualification, issuing and managing supplier corrective actions (SCAR), planning and performing internal/supplier audits and other QMS processes.
• Review Quality records and documentation for completeness, accuracy, compliance, and adherence to established requirements; identify and facilitate resolution of issues as appropriate.
• Partner with cross-functional teams to implement and maintain Quality System processes and promote consistent application of quality and compliance requirements.
• Support qualification, monitoring, maintenance, and periodic review activities associated with assigned Quality System processes, systems, suppliers, equipment, or records.
• Generate, analyze, monitor, and communicate Quality System data, metrics, trends, and other information used to evaluate QMS performance and identify opportunities for improvement.
• Provide guidance and training to employees on Quality System requirements, procedures, systems, and good documentation practices.
• Support internal, external, corporate, customer, notified body, and regulatory audits and inspections, including preparation and follow-up activities.
• Participate in or support investigations, nonconformances, CAPA, risk assessments, and other Quality processes requiring Quality Systems expertise.
• Administer or support electronic systems used to manage Quality processes, records, training, or compliance activities.
• Lead or participate in Quality System improvement initiatives, implementation activities, special projects, and cross-functional or cross-site programs.
• Support other Quality System activities, including post-market, vigilance, audit, and compliance activities, based on business needs, individual experience, and assigned responsibilities.
• Maintain applicable Quality records and ensure activities are performed in accordance with established data integrity and documentation requirements.
• Perform other functions as required.

Education, Experience and Qualifications

• Bachelor's Degree in engineering, life sciences or related field required
• Master's Degree preferred
• 3+ Years in related field or demonstrated competence within a cGMP corporate environment required
• Experience using Microsoft Office (MS Word, Excel, PowerPoint) required
• Good communication skills
• Service oriented mentality and a strong focus on customer needs
• Strong independent / cross-disciplinary skills
• Ability to work independently with minimal supervision as well as with a team
• Ability to work in a regulated environment
• Ability to train team members on basic group procedures and tasks
• Effective process management and analytical skills
• Experience in Quality System Standards and Regulations such as ISO 13485, 21CFR820 and IVDR
• cGMP
• Document and Change Control
• Quality Auditing
• CAPA
• Nonconformance Process
• Complaint / vigilance processes
• Problem-solving skills
• Ability to analyze trend data
• High degree of initiative, good judgement and decision-making skills
• Computer skills and software knowledge
• Proficiency in Microsoft Office applications
• Familiarity with SmartSolve or other eQMS software, SAP or other enterprise software is desirable

Travel Requirements

10% Travel to supplier sites for auditing purposes