- Energy Based Devices (EBD) and EBD Medical Devices.
- Based Device ExperienceKnowledge of Class II, 510K, 21CFR 820, ISO 13485, IEC 606011, ISO 14971 experienceExperience managing a team of 5 10 global staffPreferred:Certification(s) ASQ Certified Quality Engineer or equivalentKnowledge, Skills, and AbilitiesRequired:Proficient in all MS Office applicationsDemonstrated organizational skills, ability to independently prioritize work and detail orientedStrong verbal, written communication, and emotional intelligence skillsAbility to effectively multitask and manage multiple projectsExperience with FDA, European agency regulations, cGMP regulations, and Quality Management software is highly preferredKnowledge of regulatory requirements and standards for a medical device organization (i.
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Global Associate Director/Director, Quality Assurance - Raleigh, United States - Merz North America
Description
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 nonThis 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 oversightR&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 manufacturingR&D quality oversight of preclinical and clinical planning and readiness activitiesR&D quality oversight of document reviews and regulatory submissions in support of business objectivesOversee R&D Quality project timelines as defined by department, project team, and business objectivesRisk Management:
Oversee risk management activities throughout all stages of the device development processOversee 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 processOversee the human factors engineering/usability plan, Use/misuse error analysis, usability task analysis, facilitate formative and validation protocols and reportAudits:Oversee audits (e.g.
, internal, vendor/supplier), as neededVendors/suppliers qualificationsall Merz regulatory authority inspections and certification body audits, as applicableGeneral 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 initiativesR&D
Quality Improvements:
Facilitate and support harmonization initiatives within the R&D groupFacilitate 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 compliantas related to Medical DevicesProvide updates to R&D staff, as applicable
Further Tasks:
Communicate effectively cross-functionally and raise questions/issues to the attention of executive management, as appropriateProvide support to other R&D staff as needed and perform duties and assignments as requiredOther duties as assigned:Additional duties as needed to support the business and overall company objectivesJob Related Qualifications/SkillsProfessional ExperienceRequired:Minimum 15 years relevant Quality medical device development experienceEnergy
Ability to work effectively in a global, matrix environmentPreferred:
Ability to travel up to 15%Education:Required:Bachelor's Degree in Engineering or Life/Health SciencesPreferred:Master's DegreeEqual Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThe 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 c)
