Global Associate Director/Director, Quality Assurance - Merz North America, Inc

The Global Associate Director/Director, Quality Assurance, is responsible for the global strategic management and oversight of R&D Quality activities and associated staff related to Good Manufacturing Practices (GMP) for non-Energy Based Devices (EBD) and EBD Medical Devices.  Activities include, but not limited to general Product Development / Design Control customer input, specification development, verification and validation testing, manufacturing transfer, risk assessment, usability, design change control, etc. This role will operate as a liaison among the various R&D functions and the Quality Operations department to assure global strategic alignment and compliance.

Essential Duties and Responsibilities: 

• Staff Management: Responsible for the management of 5-10 global R&D Quality staff including performance management, training, coaching, mentoring, and task oversight
• R&D Quality Management and Oversight: Responsible for the global strategic oversight of R&D Quality GMP activities as related to Medical Devices (non-EBD and EBD) in support of Project Teams and R&D overall to assure global compliance. Including:
  • Quality activities for medical device manufacturing and Design & Development activities throughout all stages of the device development process (e.g. general Product Development / Design Control customer input, specification development, verification and validation testing, manufacturing transfer, risk assessment, usability, design change control)
  • Leading teams through Design Control requirements while maintaining compliant Design History Files and support tech transfers to manufacturing
  • R&D quality oversight of preclinical and clinical planning and readiness activities
  • R&D quality oversight of document reviews and regulatory submissions in support of business objectives
  • Oversee R&D Quality project timelines as defined by department, project team, and business objectives
• Risk Management: 
  • Oversee risk management activities throughout all stages of the device development process
  • Oversee the risk management plan, risk file and risk report for assigned projects
• Human Factors Engineering: 
  • Oversee human factors/usability activities throughout all stages of the device development process
  • Oversee the human factors engineering/usability plan, Use/misuse error analysis, usability task analysis, facilitate formative and validation protocols and report
• Audits:
  • Oversee audits (e.g., internal, vendor/supplier), as needed
    • Vendors/suppliers qualifications
    • all Merz regulatory authority inspections and certification body audits, as applicable
• General R&D Support:
  • Support R&D related activities including but not limited to SOP creation and maintenance, NCRs, DCNs, CAPAs, deviations, change requests, archival, corporate, and departmental initiatives
• R&D Quality Improvements:
  • Facilitate and support harmonization initiatives within the R&D group
  • Facilitate and support projects to improve R&D compliance and operational efficiencies
• Quality Intelligence: 
  • Stay informed of the latest updates related to applicable regulations to ensure R&D Quality policies and procedures remain compliant as related to Medical Devices
  • Provide updates to R&D staff, as applicable
• Further Tasks: 
  • Communicate effectively cross-functionally and raise questions/issues to the attention of executive management, as appropriate
  • Provide support to other R&D staff as needed and perform duties and assignments as required
• Other duties as assigned: 
  • Additional duties as needed to support the business and overall company objectives

Job Related Qualifications/Skills

Professional Experience

• Required:
  • Minimum 15 years relevant Quality medical device development experience
  • Energy-Based Device Experience
  • Knowledge of Class II, 510K, 21CFR 820, ISO 13485, IEC 606011, ISO 14971 experience
  • Experience managing a team of 5-10 global staff
• Preferred:
  • Certification(s) – ASQ Certified Quality Engineer or equivalent

Knowledge, Skills, and Abilities

• Required:
  • Proficient in all MS Office applications
  • Demonstrated organizational skills, ability to independently prioritize work and detail oriented
  • Strong verbal, written communication, and emotional intelligence skills
  • Ability to effectively multitask and manage multiple projects
  • Experience with FDA, European agency regulations, cGMP regulations, and Quality Management software is highly preferred
  • Knowledge of regulatory requirements and standards for a medical device organization (i.e., 21CFR820, ISO 13485, ISO 14971, IEC 62304)
  • Ability to work effectively in a global, matrix environment
• Preferred:
  • Ability to travel up to 15%

Education:

• Required: 
  • Bachelor’s Degree in Engineering or Life/Health Sciences
• Preferred:
  • Master’s Degree

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) Research and Development