3 months ago
The Staff Engineer, Nonconforming Material Control / Logistics and Distribution is accountable and responsible for the overall company's Nonconforming Material Control / Logistics and Distribution processes. The position is the Global Process Owner and oversees the Quality processes related to the Nonconforming Material Control / Logistics and Distribution functions. The position will lead the development, governance and integration of Nonconforming Material Control / Logistics and Distribution into our global Quality Management System (QMS). Accountable for initiating and supporting quality systems activities in all aspects of the business, including identification and implementation of continuous process improvement activities. The qualified candidate will be able to demonstrate leadership capability and skills necessary to lead a global team through assessment of existing Nonconforming Material Control / Logistics and Distribution process gaps, creation of interim and future state process solutions and monitor implementation for compliance to applicable FDA regulations.
* Oversee and lead the Company's processes, system development, and implementation for the following elements of the Quality system:
* Control of non-conforming material
* Distribution, handling and storage of material
* Inspection, test, and measurement
* Material identification and traceability
* Maintaining policies and procedures and identifies and drives improvement in the Nonconforming Material Control / Logistics and Distribution processes to ensure compliance with local, state and federal environmental regulations and standards including compliance with all Food & Drug Administration (FDA) and European Union Medical Device Directives (MDD) as well as all other applicable global regulatory requirements.
* Maintains up-to-date knowledge, develops and implements tactical plans to meet Company and Corporate objectives and ensures proactive compliance to FDA & EU regulations and other applicable worldwide standards and requirements specifically as related to medical device industry and quality system regulations.
* Collaborates across the organization and builds working relationships with Business Units and partners to ensure process solutions are compliant, efficient and adaptable to business units, sites and functions throughout the world.
* Provides Subject Matter Expertise and assures implementation of best practices for Nonconforming Material Control / Logistics and Distribution functions to the global organization.
* Functions as global representative for company's Nonconforming Material Control / Logistics and Distribution processes during Agency / 3rd Party Audits and assists in the preparation and submission of audit responses and requests for information to FDA, Notified Body and other Regulatory Bodies.
* Ensures our global Nonconforming Material Control / Logistics and Distribution strategy adds value to the organization through risk reduction and cost improvement.
* Utilize Danaher Business System (DBS) tools to drive compliance and effective processes
* Global travel 25-30% of the role.
* A Bachelor's degree with 14 years of experience or Master's degree with 12 years of experience, preferably in areas of life sciences, engineering, or quality assurance.
* Professional designations are not required but training and certificates in quality or regulatory affairs would be a plus (e.g. CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean Principles)
* Strong knowledge of Quality, Regulatory compliance, and operations systems and processes, including GMP and QSR requirements for medical devices. (ISO13485, FDA's QSRs, EU's MDD, Canadian Regulations) is required. Proficiency in the Microsoft Office suite of products is required. American Society for Quality certification is preferred.
* Demonstrates knowledge of domestic and international quality systems and other standards such as FDA QSR, MDD, CMDCAS, SFDA, JPAL, ISO 13485, ISO 14971 and other applicable standards and regulations.
* Possess a broad knowledge of surrounding areas including Regulatory & Compliance Development.
PERSONAL SKILLS / ATTRIBUTES:
* Express abstract and controversial ideas clearly and effectively; ensure communications, key decisions and strategies are understood in all settings.
* Develop strategic goals and objectives from knowledge base and understanding of a customer's business.
* Manage changing conditions, processes and approaches; lead organizations through change effectively.
* Ability to adopt a systemic view of process improvement and to advise process improvement teams to reach goals.
* Leadership: Possess demonstrable leadership skills; has the ability to move others to action, including peers, superiors and subordinates. Demonstrate a positive, results-oriented style. Able to develop others, and manage performance of team through coaching and feedback, willing/able to share personal knowledge and experience with others.
* Communication Ability: Ability to develop and articulate an effective flow of ideas and information that generates understanding and creates a climate in which others are informed and want to participate. Communicates complex concepts into everyday language.
* Courage: Not afraid to stand up for his/her beliefs or voice an unpopular opinion. Is looked at for direction in a crisis. Willing to try new ways without fear of failure. Challenges the status quo. Takes stands to resolve important issues. Energized by tough challenges. Is comfortable with change.
* Analyzing & Problem Solving Skills: Use an analytical approach; evaluate a situation from varying perspectives to create well-reasoned solutions. Uses rigor and logic to solve difficult problems, provides honest analysis and looks beyond the obvious. Is able to offer options with a clear evaluation of the risk. Demonstrates continuous learning and looks for opportunities to create process improvements.
* Organizational Agility: Able to foster excellent relationships and credibility quickly at all levels of the organization. An ability to create a partnership atmosphere with internal and external resources while achieving key operating objectives. Can see and understand what drives policies, practices, and procedures.
* Customer & Patient Focus: This individual needs to understand company's customers and competition to maximize opportunities and advantages, and search for ways to leverage the company's current position. Advocates for patient safety and health above all else.
* Results Focused: A confident individual who provides a good balance of risk taking and sound judgment in order to deliver optimal results. Is able to drive goal attainment in others with energy and focus.
* Character: A professional of unquestionable integrity, credibility and character who has demonstrated high moral and ethical behavior.
14 days ago
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13 days ago
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