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Medical Device Quality Management System Specialist

Vector Surgical
Menomonee Falls, WI

Quick Apply

Job Details

Full-time
12 days ago

Benefits

Health insurance
Dental insurance
401(k)
Paid time off
Vision insurance

Qualifications

Microsoft Word
Laboratory procedures
Content creation for technical audiences
Presentation software
Procedural guides
Spreadsheets
ERP systems
Technical writing experience within manufacturing
Corrective and preventive actions (CAPA)
Databases
Production validation processes
Medical device manufacturing facility experience
Quality improvement
Compliance documentation
Data analytics
Regulatory/legal compliance standards in production
Collaboration with manufacturing teams
Biomedical regulatory compliance
Sterile products production
ISO 13485
Cross-functional communication
FDA regulations

Full Job Description

JOB DESCRIPTION SUMMARY

Vector Surgical is an award-winning medical device company. Small yet dynamic, we are growing quickly and looking for an outstanding individual for our Medical Device Quality Management System Specialist.

The Quality Management System (QMS) Specialist reports to the Quality Assurance System Manager and supports the implementation, maintenance, and continuous improvement of the company's Quality Management System (QMS). This role is responsible for executing day-to-day quality system activities, maintaining quality records and documentation, coordinating quality processes, supporting audits and supplier quality activities, performing quality control testing, and data analysis. The position works independently from Production and R&D while collaborating closely with Manufacturing, Engineering, and external suppliers to ensure compliance with applicable medical device regulations and company procedures.

KEY RESPONSIBILITIES

1. Quality Management System Support

Support the Quality Manager in maintaining and improving the Quality Management System in accordance with ISO 13485, FDA regulations, and company procedures.
Prepare quality metrics, trend analyses, dashboards, graphs, and presentations for Management Reviews and other Quality reviews.
Maintain quality records and ensure timely completion of routine QMS activities.
Monitor quality system performance, identify opportunities for improvement, and support implementation of quality improvement initiatives.
Provide quality support for production activities.
Maintain production quality tracking spreadsheets and quality databases.
Support process validation activities.

2. Document Control

Develop, revise, and maintain quality system documentation, including procedures, work instructions, specifications, forms, and quality records.
Review batch-related documentation, including Device History Records (DHR), label proofing, and quality control records for completeness and compliance.
Coordinate document revisions and document control activities.
Support the Quality Manager in the document approval process.

3. Quality Control

Perform laboratory quality control activities, including internal production testing, environmental monitoring, and other laboratory analyses as applicable.
Maintain laboratory records, quality control data, and quality logs.
Record, analyze, and communicate quality control results; advise about trends and opportunities.
Support investigations related to quality control findings.

4. Complaint Handling and CAPA

Coordinate the complaint handling process from receipt through closure.
Maintain complaint files and complaint metrics.
Track CAPAs, nonconformances, and effectiveness verification activities.
Participate in investigations, root cause analysis, and implementation of corrective and preventive actions.

5. Supplier Quality

Support supplier qualification, ongoing supplier performance monitoring and supplier audits.
Coordinate Supplier Corrective Action Requests (SCARs) and communicate quality nonconformances to suppliers.
Provide quality input for supplier documentation and agreements.

6. Audits and Regulatory Compliance

Participate in planned internal audits.
Assist the Quality Manager in planning, coordinating, and supporting external audits and regulatory inspections.
Maintain audit records and support follow-up of audit findings.

REQUIRED COMPETENCIES

1. Skills

Experience using Quality Management Systems in regulated industries.
Familiarity with medical device regulations, including ISO 13485 and FDA Quality System Regulations (21 CFR Part 820/QMSR).
Understanding of sterile medical device manufacturing, labeling, validation, and regulatory requirements.
Knowledge of complaint handling, CAPA, supplier quality, document control, and audit processes.
Strong analytical and data management skills.
Excellent technical writing skills for procedures, specifications, and quality documentation.
Attention to detail is a must.
Ability to work independently while effectively supporting cross-functional teams.
Proficiency with Microsoft Excel, Word, PowerPoint, electronic Quality Management Systems (eQMS), and ERP systems.
Effective communication and interpersonal skills.

2. Qualifications

Bachelor's degree in Engineering, Life Sciences, Chemistry, Microbiology or another related scientific discipline that includes laboratory coursework and hands-on laboratory training as part of the curriculum.
Minimum 3 years of experience in Quality Assurance or Quality Management Systems within a highly regulated industry, preferably medical devices or pharmaceuticals.
Laboratory experience involving microbiological, physical, and chemical testing is preferred.
Experience supporting manufacturing and engineering teams in a regulated medical device environment.
Internal Auditor training or certification (ISO 13485 or equivalent) is preferred.
ASQ Certified Quality Engineer (CQE) or equivalent quality certification is desirable.

This is an office-based position located in Menomonee Falls, Wisconsin; relocation is not provided.

Benefits:

401(k)
Dental insurance
Health insurance
Paid time off
Vision insurance

Work Location: In person

Quick Apply

Refine Your Search

Medical Records Manager jobs

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Health Information Manager

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Electronic Medical Records Project Manager - Ambulatory Monitoring and Diagnostics (Central/Eastern US)

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