Manager, Quality Assurance

The Manager, Quality Assurance (QA) will ensure compliance within the company’s Quality Management Systems (QMS) adhering to all various state, federal, and international laws/regulations that apply to Ortho Technology, Inc.’s (OT) business operations. The QA Manager serves as the Quality Representative for MDSAP and ISO 13485 and must coordinate with other departments and co-workers to operate and perform critical due diligence of processes.

This position is responsible to manage the implementation of quality system processes to ensure products or services are designed and produced to meet or exceed customer expectations and regulatory requirements. This involves assuring quality standards (FDA 21 CFR 820, ISO 13485:2016, CMDCAS, Medical Device Regulation (MDR) and Canadian Medical Device requirements Japan and Brazil requirements?) with respect to such processes as CAPA, Complaints, Design Controls (Technical Files), Document Controls, Nonconforming Materials, Receiving and Final Inspection and Internal Auditing.

KEY RESPONSIBILITIES: 

• Direct and daily activities of the site Quality Assurance support staff (includes Document Control/Training Personnel and Quality Specialists/Associates) that support CAPAs, Complaints, Nonconformances and Receiving Inspection to ensure compliance to quality standards/regulations.
• Manage the Corrective and Preventive Action (CAPA) process and teams in response to concerns identified through complaints, nonconforming materials or other various activities. Provide guidance to CAPA owners on the typical CAPA tools for performing root cause investigations (5 Whys, Fishbone Diagram, etc.).
• Supervise the Document Control and QMS Training activities including the change order process (for product and documents), control of documents and quality records. Also support the training tasks tied to procedures and Quality Initiatives including maintenance of training records. Provide the required metrics and KPI trend data to report regularly to leadership.
• Provide Quality Analytics reports to the business leadership on a regular basis, including periodic Management Review meetings.  Interpret trends and present improvement plans to address product and process issues.
• Effectively manage and present relevant KPI’s; lead the process to identify root cause and drive corrections and corrective actions related to product and process improvement.  Support Quality Engineering functions, and related processes to drive supplier, product and process improvement.
• Oversee the site Supplier Quality process including quality agreements, supplier assessments and audits, supplier corrective action requests (SCARS) and metrics used to monitor supplier performance.
• Develop, establish, and maintain QA processes, procedures and controls ensuring that performance and quality of products conform to established standards and regulations.
• Responsible for Risk Management, communicating risk policies and processes for the organization.  Ensures risk management procedures are fully effective and followed throughout appropriate business tasks involving the Quality Management System.
• Provide guidance to Operations personnel in interpreting governmental regulations, agency guidelines and internal policies to assure compliance
• Participate in facility and QSR inspections by the Food and Drug Administration (FDA), Notified Body and internal GMP audits
• Represent Quality Assurance in the Change Control Board (CCB) meetings to review and disposition Change Orders (CO)
• Ensure compliance with department budget requirements.
• Support the documentation process for Device Master Records. Propose, draft, review and approve new or revised SOPs, job instructions and related forms relative to the quality assurance program or other programs which may impact the Quality Management System.
• Evaluate employees through performance reviews, ongoing coaching and feedback methods.  Analyze and resolve or assist employees in solving work issue.  Maintain discipline, morale and team relationship within the QA department.
• Participates in special projects and performs other duties as required.

SPECIFIC KNOWLEDGE & SKILLS: 

• Proficiency in the Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, Teams). Working knowledge of additional applications such as Visio, Access, Power BI and SharePoint a plus.
• Experience using quality system applications is a plus.
• Knowledge of EU MDR Technical File creation and maintenance is desired.
• Demonstrated ability to lead and manage staff of employees while driving effective and
• efficient processes.
• Demonstrated record of successfully leading quality improvement projects
• Ability to effectively problem-solve through critical thinking and root-cause analysis with
• minimal direction and make decisions with confidence
• Ability to prioritize, multi-task and adapt to change
• Ability to work effectively in a team environment and build strong working relationships
• High degree of initiative and self-motivation with a strong sense of accountability
• Experience leading audits and interactions with 3rd party regulatory agencies, including
• Notified Bodies, FDA, etc. 
• Medical device experience a must.  Thorough knowledge of quality system regulations, i.e., FDA 21 CFR 820, QSR, ISO 13485, MDSAP, EU MDR. Relevant training / certifications (i.e., ASQ Certification) a plus.

GENERAL SKILLS & COMPETENCIES: 

• Strong management and leadership skills and ability to attract, retain, motivate, develop and mentor team members for high performance
• Outstanding verbal and written communication skills and ability to resolve disputes effectively
• Excellent presentation and public speaking skills
• Excellent independent decision making, analysis and problem solving skills
• Understand and act on financial information that contributes to business profitability
• Ability to plan and manage successful projects; understand available resources, develop timeline, budget, assign tasks and areas of responsibility
• Lead team(s) to achieve company goals in creative and effective ways
• Excellent planning and organizational skills and techniques
• Communicate effectively with senior management
• Good negotiating skills and ability to effectively manage outsourced relationships
• Ability to influence, build relationships, understand organizational complexities and manage conflict
• Broad professional and managerial skills with a good understanding of industry practices and company policies and procedures
• Ability to lead virtual teams

MINIMUM WORK EXPERIENCE: 

Typically 10 or more years of increasing responsibility and complexity in terms of any applicable professional experience; 1 or more years of management experience.

PREFERRED EDUCATION: 

Typically a Bachelor's Degree or global equivalent in related discipline. Master's degree or global equivalent a plus.

TRAVEL / PHYSICAL DEMANDS:

Travel typically less than 10%. Office environment. No special physical demands required.

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

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