Quality Assurance Specialist

Henry Schein • Lenexa, KS

2d

About The Position

KEY RESPONSIBILITIES: Typically responsible for two or more of the following duties: Assist with preparing, documenting and conducting Quality Assurance activities related to servicing and repair operations, private labeling activities, and distributions activities of Medical Devices. Stay current with new or potential business opportunities, and prepare for all QA activities. Research applicable FDA, ISO and ASTM regulations and standards to ensure the company’s ongoing compliance with U.S. and International Regulatory Requirements. Participate in and lead CAPA activities. Approve packaging/labels for all products to assure compliance with regulatory requirements Participate in document control activities including generating, reviewing, implementing, and releasing document control orders. Participate in the training program. Participate in special projects and perform other duties as required. SPECIFIC KNOWLEDGE & SKILLS: General knowledge of ISO 13485: 2016/A11:2021 certification and maintenance. GENERAL SKILLS & COMPETENCIES: Professional skills with an understanding of industry practices and company policies and procedures. Developing proficiency with tools, systems, and procedures. Good planning/ organizational skills and techniques. Developing problem solving skills. Good writing and communication skills. Excellent conflict resolution skills. Good decision making skills. Excellent interpersonal skills. Exercise judgment within defined procedures and practices to determine appropriate action. Direction from manager/director is needed on some issues. WORK EXPERIENCE: Typically 2 to 4 years of related professional experience. PREFERRED EDUCATION: Bachelor's Degree or global equivalent in Pharmaceutical Sciences, Chemistry or related discipline. Typically hold 1 or more industry certifications (ASQ, RAPS, ISO or equivalent). TRAVEL/ PHYSICAL DEMANDS: Less than 20% travel to and from suppliers and/or HSI facilities Office environment. No special physical demands required. KNOWLEDGE: Intermediate level professional role. Some evaluation, originality or ingenuity required to perform tasks. Know and apply the fundamental concepts, practices, and procedures of a particular field. Apply company policies and procedures to resolve a variety of issues.

Requirements

• General knowledge of ISO 13485: 2016/A11:2021 certification and maintenance.
• Professional skills with an understanding of industry practices and company policies and procedures.
• Developing proficiency with tools, systems, and procedures.
• Good planning/ organizational skills and techniques.
• Developing problem solving skills.
• Good writing and communication skills.
• Excellent conflict resolution skills.
• Good decision making skills.
• Excellent interpersonal skills.
• Exercise judgment within defined procedures and practices to determine appropriate action.
• Direction from manager/director is needed on some issues.
• Typically 2 to 4 years of related professional experience.

Nice To Haves

• Bachelor's Degree or global equivalent in Pharmaceutical Sciences, Chemistry or related discipline.
• Typically hold 1 or more industry certifications (ASQ, RAPS, ISO or equivalent).

Responsibilities

• Assist with preparing, documenting and conducting Quality Assurance activities related to servicing and repair operations, private labeling activities, and distributions activities of Medical Devices.
• Stay current with new or potential business opportunities, and prepare for all QA activities.
• Research applicable FDA, ISO and ASTM regulations and standards to ensure the company’s ongoing compliance with U.S. and International Regulatory Requirements.
• Participate in and lead CAPA activities.
• Approve packaging/labels for all products to assure compliance with regulatory requirements
• Participate in document control activities including generating, reviewing, implementing, and releasing document control orders.
• Participate in the training program.
• Participate in special projects and perform other duties as required.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level