About the Role
<p><b><u>ESSENTIAL FUNCTIONS (RESPONSIBILITIES)</u></b></p>
<p>Essential functions include, but are not limited to, the following:</p>
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<p>Manages and leads the Quality Systems and Quality Engineering activities for the designated BU.</p>
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<p>Manages and support validation activities related to processes, products, materials and projects supporting the designated BU and other BUs when requested.</p>
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<p>Develops and implements strategic direction for the designated BU consistent with Hypodermic Platform, MDS and BDX Quality strategy.</p>
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<p>Provides effective Quality Management leadership to designated BU BLT and contributes to the Columbus Quality leadership Team in order to meet quality, business and organizational objectives of the BD Medical: Medication Delivery Solutions.</p>
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<p>Provides effective leadership in teamwork development, effective communication and quick responses to customers. Drives improvements towards customer centricity.</p>
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<p>Implements effective CAPA process focused on reduction of causes of customer complaints, non-conformances, excursions, rejections and waste.</p>
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<p>Assesses and builds organizational capability for Quality management, particularly in the selection and mentoring of dedicated high caliber QEs and QC Reps (Quality Engineering and Quality Representatives) professionals.</p>
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<p>Evaluates, facilitates, designs, implements and continually improves quality systems and business processes, including product controls to achieve quality goals and to maintain a high level of regulatory compliance.</p>
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<p>Management representative for the designated BU with regards to all Quality System regulation issues.</p>
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<p>Enhances BD Columbus designated BU management’s understanding and application of broad scope Quality Management principles through education, training, and workshops.</p>
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<p>Provides leadership and guidance in integrating Quality Management and continuous improvement into the Columbus business strategic planning process.</p>
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<p>Champions the needs of both internal & external customers by factoring these needs into planning & decisions at all levels.</p>
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<p>Builds a strong interactive working and strategic relationship with appropriate designated Platform Quality, R&D and Regulatory management groups.</p>
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<p>Builds & sustains a Columbus business culture that accepts Excellence as an expectation, compliance as an outcome and goal.</p>
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<p>Provides coaching, and facilitation support to all levels at the designated BU Columbus plant.</p>
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<p>Interfaces with Regulatory Agencies (FDA, ISO notified body, other foreign regulatory bodies).</p>
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<p>Leads and supports customer audits, internal audits.</p>
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<p>Recommends and implements necessary actions and programs to continually upgrade the Quality Management/Quality System/Quality Engineering capability of the designated BU.</p>
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<p>Engage and deploy zero customer complaints program.</p>
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<p>Support the designated BU to meet: CPM, Financial goals, Waste target, CI projects, Deliveries, Zero past due CAPA, BBQ, 5S.</p>
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<p>Other duties, as assigned.</p>
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<p> </p>
<p><strong><u>REQUIREMENTS:</u></strong></p>
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<p>Bachelor of Science degree in Engineering or Science related field.</p>
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<p>Minimum 5 years’ experience in quality, with a minimum of 3 years in the medical device industry</p>
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<p>Experience with Validations, CAPA, Statistical Analysis.</p>
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<p>Experience with high volume manufacturing processes.</p>
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<p>Experience in Lean/Six Sigma.</p>
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<p>Experience managing and leading people required.</p>
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<p>Experience communicating with all levels of the organization.</p>
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<p>Capable to manage under pressure and set priorities accordingly.</p>
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<p>Full support to a 24/7 operation.</p>
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<br />
Security Clearance Required: No<br />
Visa Candidate Considered: No<br />
<strong>Compensation</strong><br />
Base Salary - USD $120,000 to $135,000