Merz Aesthetics
Director, Global Device Quality Or Sr. Director, Global Device Quality
Merz Aesthetics, Madison, Wisconsin, United States
Director, Global Device Quality
Join to apply for the Director, Global Device Quality role at Merz Aesthetics. About Merz Aesthetics
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 lead your team to achieve business objectives. What You Will Do
Energy Based Device Quality: Leader of Global Quality for 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 authority for final disposition. 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 avoid mix-ups, damage, deterioration or contamination. Equipment is appropriately designed, validated, and maintained. Internal audits of manufacturing completed by the Compliance function. Compliance with standards and procedures; maintenance of records to demonstrate control of the Quality System.
State of the Art: Evaluate and implement new technologies per Quality System Standards and Regulations; identify quality improvement initiatives to improve compliance, quality levels, and operational efficiency. Quality Metrics and Design Control: Monitor quality metrics to identify systemic issues; ensure proper investigation, corrective and preventive action; collaborate with R&D, Operations, Clinical & Marketing to ensure proper design controls and process validation. Quality System Management: Strategic planning for analysis and information concerning complaint trends and development of new products for consideration by management; contribute to regular Management Review materials. Adherence to Regulations: Ensure compliance of the Quality Management System for Energy Based Devices. Operate to ISO 13485 and 21CFR Part 820 FDA regulations, MDD/MDR, CMDR, etc. Interface with external agencies as required, including the FDA and Notified Bodies. Product Development and Change Control: Collaborate with R&D and Sustaining Engineering on quality assurance for new and on-market products to address problems. Personnel Management: Supervise and provide direction to assigned staff. Global Alignment: Provide strategic and tactical support to Global Quality initiatives. Organizational Support: Maintain positive working relationships and involve relevant representatives from affected departments. Budget Management: Manage departmental budgets in line with approved targets. Minimum Requirements
Bachelor of Engineering (B.E.) or Physical Science or equivalent Director: 10+ years in the medical products industry with direct experience with Energy Based Medical Devices Sr. Director: 15+ years in the medical products industry 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. Strong organizational skills with ability to prioritize tasks and meet deadlines. Ability to host, facilitate and execute audits with internal and external audiences. Knowledge of US and international regulations and ICH guidelines. Highly computer literate (Word, Excel, PowerPoint); ability to prepare documents for submission. Ability to work effectively in a global, matrix environment. Ability to work independently as well as lead direct reports. Strong interpersonal skills and collaboration with cross-functional experts. Job Details
Seniority level: Director Employment type: Full-time Job function: Quality Assurance Industries: Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Merz Aesthetics. Sign in to set job alerts for “Director Global Quality” roles.
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Join to apply for the Director, Global Device Quality role at Merz Aesthetics. About Merz Aesthetics
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 lead your team to achieve business objectives. What You Will Do
Energy Based Device Quality: Leader of Global Quality for 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 authority for final disposition. 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 avoid mix-ups, damage, deterioration or contamination. Equipment is appropriately designed, validated, and maintained. Internal audits of manufacturing completed by the Compliance function. Compliance with standards and procedures; maintenance of records to demonstrate control of the Quality System.
State of the Art: Evaluate and implement new technologies per Quality System Standards and Regulations; identify quality improvement initiatives to improve compliance, quality levels, and operational efficiency. Quality Metrics and Design Control: Monitor quality metrics to identify systemic issues; ensure proper investigation, corrective and preventive action; collaborate with R&D, Operations, Clinical & Marketing to ensure proper design controls and process validation. Quality System Management: Strategic planning for analysis and information concerning complaint trends and development of new products for consideration by management; contribute to regular Management Review materials. Adherence to Regulations: Ensure compliance of the Quality Management System for Energy Based Devices. Operate to ISO 13485 and 21CFR Part 820 FDA regulations, MDD/MDR, CMDR, etc. Interface with external agencies as required, including the FDA and Notified Bodies. Product Development and Change Control: Collaborate with R&D and Sustaining Engineering on quality assurance for new and on-market products to address problems. Personnel Management: Supervise and provide direction to assigned staff. Global Alignment: Provide strategic and tactical support to Global Quality initiatives. Organizational Support: Maintain positive working relationships and involve relevant representatives from affected departments. Budget Management: Manage departmental budgets in line with approved targets. Minimum Requirements
Bachelor of Engineering (B.E.) or Physical Science or equivalent Director: 10+ years in the medical products industry with direct experience with Energy Based Medical Devices Sr. Director: 15+ years in the medical products industry 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. Strong organizational skills with ability to prioritize tasks and meet deadlines. Ability to host, facilitate and execute audits with internal and external audiences. Knowledge of US and international regulations and ICH guidelines. Highly computer literate (Word, Excel, PowerPoint); ability to prepare documents for submission. Ability to work effectively in a global, matrix environment. Ability to work independently as well as lead direct reports. Strong interpersonal skills and collaboration with cross-functional experts. Job Details
Seniority level: Director Employment type: Full-time Job function: Quality Assurance Industries: Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Merz Aesthetics. Sign in to set job alerts for “Director Global Quality” roles.
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