Job details

Description

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!

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