Director, Global Device Quality Or Sr. Director, Global Device Quality (Biotech)

About Us
Founded in 1908, Merz is a successful, family-owned specialty healthcare company with a rich history. As a leading global aesthetics business, our award-winning portfolio of injectables, devices, and skincare products empowers healthcare professionals to enhance confidence through aesthetic medicine. Our purpose is to fuel confidence by helping people look better, feel better, and live better. We believe you do not have to choose between living life and making a living. Live your best life with Merz Aesthetics.

 

A Brief Overview
As head of Global Device Quality, you are accountable for the Development, Execution and Delivery of domestic and international Quality Strategies for Energy Based Devices at Merz Aesthetics. You will partner with R&D, Operations, Engineering, Clinical & Marketing to assure all Quality Objectives are Identified and Fulfilled, Drive Continuous Improvement and Motivate and Lead your Team to Achieve Business Objectives.

 

What You Will Do

• Energy Based Device Quality: Leader of Global Quality Merz Energy Based Devices. Manage personnel within the Quality Organization. Act as liaison between Global Merz sites and functions.
• Product Quality: Develop, conduct, control and monitor processes to ensure that product conforms to its specifications. This includes but is not limited to:
  • Documented Instructions (appropriate SOPs, DHR, etc.).
  • Incoming materials meet required specifications.
  • In-process monitoring during manufacturing.
  • Final release testing using representative samples.
  • Control of material/product and status.
  • Non-Conforming product is appropriately controlled, including the authority for the final disposition of non-conforming product.
  • Establish and maintain corrective & preventive action procedures.
  • Change control. Environmental & Contamination Control of Manufacturing.
  • Personnel are appropriately qualified and trained.
  • Buildings & facilities are suitable in design and space.
  • Product is appropriately handled, stored, and distributed to ensure mix-ups, damage, deterioration, contamination, or other adverse effects to product do not occur.
  • Equipment is appropriately designed, validated, and maintained.
  • Internal audits of manufacturing is completed by the Compliance function.
  • Compliance with standards, internal procedures, etc. Maintenance of records to demonstrate control of the Quality System as outline above.
• State of the Art: Evaluate and Implement New Technologies per Quality System Standards, Quality System Regulations, and Identify new quality improvement initiatives / projects in accordance with cGMP Expectations to Improve Compliance, Quality Levels (reducing defects), and Improve Operational Efficiencies.
• Quality Metrics and Design Control: Monitor quality metrics to identify systemic product and process issues assuring appropriate investigation, correction, and corrective and preventive action when needed. Partners with R&D, Operations, Clinical & Marketing to assure there is appropriate execution of design controls and process validation.
• Quality System Management: Manage and provide strategic planning for the analysis, evaluation and other information concerning factors such as complaint trends, and design and development of new products for consideration by other members of management team, including content generation for regular Management Review meetings.
• Adherence to Regulations: Ensure compliance of the Quality Management System as it pertains to Energy Based Devices. Operate to the most current version of ISO 13485 and 21CFR Part 820 FDA regulations, MDD/MDR, and Canadian Medical Device Regulations (CMDR), etc. Interface with external agencies as required including the FDA and the Notified Body.
• Product Development and Change Control: Collaborate with R&D and Sustaining Engineering regarding quality assurance of new products designed and manufactured products on market to rectify problems.
• Personnel Management: Supervise and provide direction to assigned staff in carrying out their work.
• Global Alignment: Provide strategic and tactical support to Global Quality initiatives.
• Organizational Support: Maintain positive working relationships and ensure appropriate representatives from affected departments are involved.?
• Budget Manage: Departmental Budgets in accordance with approved targets.

 

Minimum Requirements

• Bachelor of Engineering (B.E.) Or Physical Science or Equivalent
• Director: 10+ years 10 years minimum in the medical products industry required, with direct experience with Energy Based Medical Devices
• Sr. Director: 15+ years 15 years minimum in the medical products industry required, with direct experience with Energy Based Medical Devices
• 5+ years in a Quality Function
• 3-5 years in a Quality Operations Role

 

Preferred Qualifications

• Master's Degree In Engineering, Physical Science or Business
• Lean / Six Sigma Green Belt Upon Hire
• ASQ CQA, CQE, CQMOE Upon Hire

Technical & Functional Skills

• Excellent written and oral communication skills with attention to detail.
• Demonstrated strong organizational skills including ability to prioritize tasks and adhere to agreed timelines.
• Ability to host, facilitate and execute audits with internal and external audiences.
• Knowledge and understanding of US and ex-US regulations and ICH guidelines.
• Highly computer literate (Word, Excel PowerPoint), including formatting and getting documents submission-ready.
• Ability to work effectively in a global, matrix environment.
• Ability to work independently as well as direct and control the efforts of Direct Reports as applicable.
• Strong interpersonal skills and ability to collaborate effectively with various technical area experts.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor. Quality Assurance Methods Generalist