The Quality Assurance Specialist supports the project teams during the development process of new products and supports existing products when necessary. They are required to comply with Good Manufacturing Practices, ISO requirements, and other recognized standards.  

The Quality Assurance Specialist is based in a Kerecis office and reports to the Senior Manager Quality Assurance.

Essential Functions:

• Attains and maintains proficiency in the Company Critical Quality Requirements
• Assists in the development, maintenance, and implementation of processes and procedures in accordance with regulatory requirements
• Monitors, maintains, and assists with standards for validation, sterilization, risk management, and design activities
• Assists with product return procedures and associated training
• Assists with the resolution and documentation associated with customer complaints
• Conducts local vendor audits
• Participates and leads teams in Quality decisions and practices
• Other tasks and responsibilities as assigned

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time. Kerecis is an equal opportunity employer.

Competencies

• ASQ CQE or other certifications preferred
• Ability to work within the team as an individual contributor in a fast paced, changing environment
• Advanced computer skills including statistical/data analysis and report writing
• Detailed knowledge of FDA, cGMP ISO 13485, and ISO 14971
• Works with cross functional teams to complete assigned tasks
• Skill and ability to think analytically by solving problems to make decisions.
• Strong communication skills (oral and written), with excellent presentation technique
• Self-motivated problem-solver / trouble-shooter with a strong bias for action 
• Demonstrated ability to lead technically driven projects
• Ability to interact with multidisciplinary colleagues in a team environment
• Ability to motivate and guide others to meet objectives and drive actions to closure
• Innovative thinker, creative, willing to challenge established thinking
• Flexibility and adaptability in response to rapidly changing priorities
• Ability to collaborate in a cross-functional and external environment
• Comfortable coordinating with vendors by phone and email
• Strong work ethic to deliver high-quality products on time and within budget
• Proficient organizational, record keeping skills
• Proficiency in Microsoft Office suite

Education & Experience:

• BS in Engineering or Technical Field, advanced degree preferred
• 5+ years of medical device experience

Travel: 5% 

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time. Kerecis is an equal opportunity employer.