Senior Quality Systems Specialist
23 hours ago
Job Summary:
Maintain a safe work environment and ensure compliance with quality objectives and policies.
Ensure the effective execution of high complexity/impact projects that will significantly impact the Quality of the product and Compliance improvement throughout the implementation of changes involving supplier related items, validation processes, Quality Culture, risk management process improvement, change management, material controls improvement, and Quality Control items.
Key Responsibilities:
- Interface with internal constituents and external regulatory bodies regarding compliance needs as required
- Assist in the preparation of Management Review meeting presentations on a quarterly basis
- Attend project team meetings and provide assistance with validation and regulatory strategies for various projects
- May review and approve Complaint, CAPA, Audit Findings, Issue Reviews, Non-conformances investigations to provide guidance for effective investigations
- Prepare Validation Strategies and execute accordingly by writing technical reports as needed
- May create and execute validation protocols such as IQs, OQs, PQs, and/or TMVs
- Support the site with statistical techniques guidance to ensure compliance at different departments during design transfer process, sampling plan implementations or improvements, establishments of CTQs, Validation strategies, and investigations
- Provide continued quality system support by improving processes and systems and updating or creating site procedures or enterprise procedures, Inspection requirements, Test Method inspections
- Participate in third-party audits as required: Back room lead, SME, Reviewer, etc.
- May manage key quality system programs such as CAPA, Quality Culture initiatives, Non-conformance or other QMS elements programs that are to be monitored and under control
- Provide support to manufacturing lines to address issues and escalate issues to NC or CAPA process as needed
- May work with high-risk investigations to document Quality Issues resolutions involved with internal issues or customer and external regulatory bodies through CAPA, SCAR, NCR, Issue Review, External Audit findings (Regulatory bodies: FDA, DEKRA, SGS) to ensure proper and robust actions are taken to eliminate re-occurrence
- May supervise exempt and non-exempt personnel as required
- Provide guidance, coaching, and train other Quality Engineers in Engineering topics such as Validation process, Root Cause Analysis, Statistical techniques, SPC, CAPA, NCRs, etc.
- Educate employees on Compliance, ISO 13485, ISO 14791, 21 CFR 820, and 2017/745 (EU/MDR)
- Escalate Quality issues to upper management based on risk, trend, and compliance assessment
- Ensure Site Metrics comply with internal requirements and goals established
- Work with high-complexity projects to ensure a process continuous improvement is in place
- Create high-complexity Project strategies and ensure execution is completed in a timely manner
- Drive activities to reinforce Quality Culture through Quality initiatives, or processes related
- May provide coaching to engineers/auditors to promote people development and process improvement culture
- Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules
- Exhibits regular, reliable, punctual, and predictable attendance
- Contributes to continuous process improvement efforts to reduce scrap, cycle times, improve efficiency, quality culture reinforcement, and eliminate waste
- Provides a "Customer Service" attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards
- Maintains a clean, orderly, and safe workstation and environment always
- Performs other duties as assigned based on business needs
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