Quality Assurance Specialist

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.

JOB COMPLEXITY: 

Work on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Exercise judgment within defined procedures and practice to determine appropriate action. Build productive internal/external working relationships.

SUPERVISION: 

Normally receive little instruction on day to day work, detailed instruction on new projects or assignments.

PERFORMANCE REQUIREMENTS:   

Typically, to advance to a new grade, TSMs must demonstrate professional behavior and should consistently be at the high-end of meets expectations or consistently exceed expectations.

Henry Schein, Inc.  is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status

Henry Schein, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status. 

For more information about career opportunities at Henry Schein, please visit our website at: www.henryschein.com/careers

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