Quality Assurance Specialist - Vendor Qualifications & Monitoring

KEY RESPONSIBILITIES:

Typically responsible for two or more of the following duties:

• Assist with preparing, documenting and conducting Quality Assurance Audits of Distribution Centers, joint Ventures, X-Ray Centers, private label manufacturers, non-manufacturing suppliers of Medical Devices and Pharmaceuticals.

• Conduct Quality Assurance Audits as scheduled and ensure the effective and timely facilitation of suppliers and internal quality audits and follows-up on CAPAs/Observations.

• Stay current with new or potential business opportunities, and prepare for all QA activities.

• Research applicable FDA, ISO and ASTM standards to ensure the company's ongoing compliance with U.S. and International Regulatory Requirements (Medical Devices Directives and FDA QS requirements).

• Conduct annual analysis of type of audits conducted and type of observations.

• Approve packaging/labels for all private label products to assure compliance with regulatory requirements

• Provide support to Corporate Brand Development Group, answering questions pertaining to regulatory issues with outsourced products.

• Participate in special projects and perform other duties as required.

SPECIFIC KNOWLEDGE & SKILLS:

General knowledge of ISO 9001 and 13485 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.

The posted range for this position is $55,630 - $86,922 which is the expected starting base salary range for an employee who is new to the role to fully proficient in the role. Many factors go into determining employee pay within the posted range including education, prior experience, training, current skills, certifications, location/labor market, internal equity, etc.

At the time of this posting, this position is eligible for a bonus not reflected in the posted range subject to the achievement of the plan.

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