Associate Director/ Director, Quality Engineering - Merz North America, Inc

About the Company:

Family owned since 1908 Merz Aesthetics is the world’s largest dedicated medical aesthetics business. Choose Merz Aesthetics because it is unique - unique in our relationships with customers, in our products and in the way we treat each other.

As Associate Director/ Director, Quality Engineering, 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 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.

Key Responsibilities:

Associate Director:

Lead Quality Support for Design Control:

• Lead quality team in supporting operations, sustaining engineering, R&D and NPI departments in the development, verification and validation of product changes and introduction of new products and process.
• 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.

Lead Risk Management:

• Lead Risk Management activities including review and coordination of quality activities to risk.

Lead Supplier Quality and Received Goods Inspection:

• Oversee and manage the Supplier Quality Management System to include oversight of suppliers that manufacture and supply products and services to Merz (including: Biologics, Rx, OTC, Medical Devices (510K, PMA), Cosmetics and Nutritional Supplements.
• Oversee and manger the team performing received goods inspections ensuring appropriate inspection methods are established and ensure timely and compliant inspections are completed.

Support NCR and CAPA:

• Support corrective/preventive actions and product non-conformance including capturing data and investigations associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analyzing the data for the reasons of Quality Improvement and reporting.

Quality initiatives:

• Identifies and implements new quality improvement initiatives/ projects in accordance with cGMP expectations to improve compliance, quality levels (reducing defects), and improve operational efficiencies.
• Works with manufacturing and other functional groups on manufacturing regulatory compliance issue.

Adherence to Regulations:

• Ensure compliance of the Quality Management System. 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.

Director:

Energy Based Device Quality Leader: Operate as primary Quality leader for Merz Energy Based Devices.  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:

• Incoming materials meet required specifications.
• In-process monitoring during manufacturing.
• Final release testing using representative samples.
• Control if 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 are completed by the Compliance function.
• Compliance with standards, internal procedures, etc.
• Maintenance of records to demonstrate control of the Quality System as outline above.
• Documented Instructions (appropriate SOPs, DHR, etc.).

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.

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: Provide strategic and tactical support to Global Quality initiatives.

Budget: Manage Departmental Budgets in accordance with approved targets.

 Knowledge, skills and abilities (incl. languages):

• Excellent written and oral communication skills with attention to detail. Required
• Demonstrated strong organizational skills including ability to prioritize tasks and adhere to agreed timelines. Required
• Ability to host, facilitate and execute audits with internal and external audiences. Required
• Knowledge and understanding of US and ex-US regulations and ICH guidelines. Required               
• Highly computer literate (Word, Excel PowerPoint), including formatting and getting documents submission ready. Required

Knowledge of methods:

• Lean / Six Sigma Green Belt. Preferred
• ASQ CQA, CQE, CQMOE. Preferred

Personal skills:

• Ability to work effectively in a global, matrix environment. Required
• Ability to work independently as well as direct and control the efforts of Direct Reports as applicable. Required
• Strong interpersonal skills and ability to collaborate effectively with various technical area experts. Required

Experience:

Associate Director:  

• 8 years minimum in the medical products industry required
• 5 years minimum in a Quality function preferred

Director:

• 8 years minimum in the medical products industry required, with direct experience with Energy Based Medical Devices. Required
• 5 years minimum in a Quality function. Required
• 3 years minimum in a Quality Operations role. Required

Education:

• Bachelor’s Degree in a Physical Science or Equivalent. Required
• Master’s degree in physical science or Business. Preferred

Benefits:

• Comprehensive Medical, Dental, and Vision plans.
• 20 days of Paid Time Off.
• 15 paid holidays.
• Paid Sick Leave.
• Paid Parental Leave.
• 401(k).
• Employee bonuses.
• And more!

Your benefits and PTO start the date you're hired with no waiting period! Come join a company that is committed to being a trusted partner focused on our customers while not forgetting about our employees!

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c) Quality