QMS Specialist

Techtrueup • Newark, DE

4d

About The Position

Job Title: QMS Specialist
Location: Newark, DE
Long Term Contract
Job Summary:
The QMS Specialist is an individual contributor responsible for executing activities that support the Workstreams within the QMS Remediation program.
This role works closely with the QMS Strategic Lead for the Workstream to carry out day-to-day tasks, complete remediation activities, and help maintain the effectiveness of Quality System Elements, specifically CAPA, Management Controls, Document Controls, and/or Training. The successful candidate will be a hands-on contributor who follows established procedures, applies sound problem-solving, and ensures accurate and timely completion of assigned quality system remediation work.
Demonstrates an understanding of various aspects of the QMS, federal regulation, and applicable standards and applies knowledge and skills to complete a wide range of assigned tasks while participating as a key Core Team member. Exhibits good judgment in selecting methods and techniques for obtaining solutions under general guidance.

Requirements

• Proven ability to lead cross-functional teams and work across multiple workstreams
• Strong written and verbal communication skills, including executive-level updates and regulatory documentation
• Excellent technical writing skills
• Ability to present materials to director level leadership.
• Fluent in English (written and verbal)
• Strong analytical and problem-solving skills
• Highly organized with the ability to manage complex, multi-threaded remediation efforts
• Detail-oriented with a focus on compliance, sustainability, and effectiveness
• Proactive, adaptable, and comfortable operating in high-visibility, fast-paced environments
• Preferred Minimum Technical/Advanced Degree: Technical Bachelor’s Degree
• Preferred Minimum Technical/Advanced Degree: 2-4 Years with Technical Bachelor’s Degree

Nice To Haves

• Experience with Agile or equivalent Product Lifecycle Management system is beneficial.

Responsibilities

• Partner with the QMS Strategic Lead including but not limited to, redesign and implement robust QMS processes in alignment with regulatory requirements and business objectives.
• Contribute to remediation projects as needed, ensuring timely and thorough resolution of systemic issues.
• Network with internal and external stakeholders to benchmark and implement industry-leading best practices.
• Provide consultation, feedback and training on quality management principles, methodologies, and best practices to cross-functional teams at multiple sites.
• As a Core Team member, participate in QMS Remediation CAPA activities guiding the organization in root cause analysis, effectiveness checks, and sustainable corrective actions.
• Drive implementation of sustainable controls, metrics, and monitoring mechanisms to prevent recurrence of issues
• Ability to modify, maintain, and implement procedures and processes as applicable.
• Collaborate and communicate effectively with employees, peers, and cross-functional teams across all levels of the organization.
• Mentor others on BSHS quality system requirements and standards to elevate team's ability to produce high-quality products, and implement best practices that emphasize risk reduction, defect prevention, reduction in variation and waste and provide for continuous improvement.

What This Job Offers

• Career Level: Mid Level
• Number of Employees: 1-10 employees