Job Description:
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We are seeking a skilled professional to lead the coordination of change control activities and ensure compliance with internal and external change control requirements. This role will serve as the subject matter expert and administrator for change control documentation.
Key Responsibilities:
* Oversee the global Change Control process, leading change control review board activities (documentation, data, customer notifications and approvals)
* Collaborate with cross-functional teams on West change controls and provide guidance and Quality consultation to change control owners on change levels and associated tasks
* Assist change owners to outline action plans, tasks, and responsibilities to ensure execution of changes occur in a timely manner
* Drive visibility and oversight to changes across the network to ensure applicability and consistency
* Oversee assessment of change controls and assure change impact is considered across products, platforms, life cycle phases, supply chain, and processes
* Ensure change control information is accurately entered into the appropriate tracking database
* Provide mentoring and training to change owners on change control processes and tools
* Work with global, cross-functional groups, manufacturing sites, and customers as needed to determine compliance with customer specifications
* Monitor and communicate metrics and trend reports to management for the Change Control system as needed
* Collaborate on cross-functional teams in determining specification content
* Perform evaluation of change control processes and tools to drive continuous improvement activities
Required Skills & Qualifications:
Education:
* Bachelor's Degree in Science or equivalent experience required
* Master's Degree in Science or equivalent experience preferred
Experience:
* Minimum 5 years of experience in regulated Quality Assurance / Quality Control required
* Experience with qualifications, Quality Risk Management, quality systems such as ISO 13485, 21 CFR 820, ISO 14971, Medical Device Product Development Life Cycle Activities, Verification / Validation Activities, Risk Management, DHF Activities, MasterControl, SAP, Share Point, Teamcenter preferred
Preferred Knowledge, Skills & Abilities:
1. Ability to work independently, multi-task, and thrive in fast-paced environments
2. Excellent critical reading and writing skills
3. Must have effective problem-solving and interpersonal skills
4. Ability to work independently, multi-task, and thrive in fast-paced environments
5. Problem-solving including root cause failure analysis methods
6. Planning/organizational skills
7. Proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and PowerPoint
8. Able to comply with the company's safety policy at all times
9. Knowledge of cGMP, cGDP