Top 299 Complaint handling specialist medical device Jobs

Medical Device Quality Management System Specialist
Vector Surgical —Menomonee Falls, WI
- Full-time
- Microsoft Word
- Surgery
- Engineering
- Health insurance
- Dental insurance
Quick Apply
2d
Lab Program Coordinator
Renown Health —Reno, NV
- Full-time
- OSHA
- Computer literacy
- Writing skills
Sr Electrical Engineer - Medical device
Grove Technical Resources —Lafayette, CO
- $55 - $65 an hour
- Contract
- Office
- Master's degree
- Analysis skills
Quick Apply
Latvian Interpreter
LanguageLine Solutions —Remote
- $18 - $21 an hour
- Full-time
- Remote
- Background check
- 18 years or older
- Pass drug screening
- Paid training
- AD&D insurance
Tamil Interpreter
LanguageLine Solutions —Remote
- $0.60 - $0.75 an hour
- Part-time
- Remote
- Background check
- 18 years or older
- Pass drug screening
- Opportunities for advancement
- Referral program
Director of Activities
Gates Health and Rehabilitation Center —Gatesville, NC
- Weekends as needed
- Ability to lift 50 pounds
- Driver's License
- Recruiting
Quick Apply
7d
Dinka Interpreter
LanguageLine Solutions —Remote
- $0.75 - $0.90 an hour
- Part-time
- Remote
- Background check
- 18 years or older
- Pass drug screening
- Opportunities for advancement
- Referral program
Karenni Interpreter
LanguageLine Solutions —Remote
- $0.75 - $0.90 an hour
- Part-time
- Remote
- Background check
- 18 years or older
- Pass drug screening
- Opportunities for advancement
- Referral program
Fukienese Interpreter
LanguageLine Solutions —Remote
- $23 - $25 an hour
- Full-time
- Remote
- Background check
- 18 years or older
- Pass drug screening
- Paid training
- AD&D insurance
Japanese Interpreter
LanguageLine Solutions —Remote
- $18 - $21 an hour
- Full-time
- Remote
- Background check
- 18 years or older
- Pass drug screening
- Paid training
- AD&D insurance
Toishanese Interpreter
LanguageLine Solutions —Remote
- $23 - $25 an hour
- Full-time
- Remote
- Background check
- 18 years or older
- Pass drug screening
- Paid training
- AD&D insurance
Karen Language Interpreter (Spoken in Myanmar & Thailand)
LanguageLine Solutions —Remote
- $17 - $21 an hour
- Full-time
- Remote
- Background check
- 18 years or older
- Pass drug screening
- Paid training
- AD&D insurance
Chuukese Interpreter
LanguageLine Solutions —Remote
- $23 - $25 an hour
- Full-time
- Remote
- Background check
- 18 years or older
- Pass drug screening
- Paid training
- AD&D insurance
Experienced Quality Engineer – Risk Management Specialist
Manpower Group North America —Scarborough, ME
- Up to $44.78 an hour
- Temporary
- Background check
- Engineering
- Mid-level
Quick Apply
2d
Fuzhou Interpreter
LanguageLine Solutions —Remote
- $23 - $25 an hour
- Full-time
- Remote
- Background check
- 18 years or older
- Pass drug screening
- Paid training
- AD&D insurance
Packaging Specialist
Nivagen Pharmaceuticals —Sacramento, CA
- Background check
- Mid-level
- 3 years
- Health insurance
- Dental insurance
Quick Apply
Product Complaint Specialist I
Meso Scale Diagnostics, LLC. —Rockville, MD
- $59,100 - $87,900 a year
- Mid-level
- Office
- Continuous improvement
- Paid parental leave
- AD&D insurance
Quick Apply
Medical Logistics Specialist (D)
Systems Products and Solutions, Inc —Huntsville, AL
- Spanish
- Military
- English
Quick Apply
Medical Device Senior Regulatory Affairs Specialist
IsoAid, LLC —Port Richey, FL
- $69,244.73 - $99,305.49 a year
- Full-time
- Mid-level
- Office
- 3 years
- Health savings account
- Health insurance
Quick Apply
1d
Clinical Complaint Specialist
Masimo —Irvine, CA
- $80,000 - $100,000 a year
- Full-time
- Nursing
- Schematics
- RN License
- Paid parental leave
- AD&D insurance

I want to receive the latest job alert for complaint handling specialist medical device

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

complaint handling specialist medical device jobs near

Interpreter jobs in Remote

Program Coordinator jobs in Reno, NV

Quality Specialist jobs in Menomonee Falls, WI

Clinical Specialist jobs in Irvine, CA

Senior Electrical Engineer jobs in White Plains, NY

Electrical Apprentice jobs in Minnesota

Senior Electrical Engineer jobs in Knoxville, TN

Senior Electrical Engineer jobs in Portland, OR

Rf Engineer jobs in Tampa, FL

Senior Electrical Engineer jobs in New York, NY

Electrical Apprentice jobs in Ontario, CA

Medical Interpreter jobs in Albuquerque, NM

Spanish Interpreter jobs in Houston, TX

Sign Language Interpreter jobs in Minnesota

Spanish Interpreter jobs in Raleigh, NC

Medical Interpreter' jobs in Houston, TX

Medical Interpreter jobs in San Antonio, TX

Senior Quality Engineer jobs in Fort Worth, TX

Brightview Senior Living jobs in Shelton, CT

Brookdale Senior Living jobs in Albany, OR

Medical Device Quality Management System Specialist

Vector Surgical
Menomonee Falls, WI

Quick Apply

Job Details

Full-time
2 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

complaint handling specialist medical device jobs

Medical Device Quality Management System Specialist

Lab Program Coordinator

Sr Electrical Engineer - Medical device

Latvian Interpreter

Tamil Interpreter

Director of Activities

Dinka Interpreter

Karenni Interpreter

Fukienese Interpreter

Japanese Interpreter

Toishanese Interpreter

Karen Language Interpreter (Spoken in Myanmar & Thailand)

Chuukese Interpreter

Experienced Quality Engineer – Risk Management Specialist

Fuzhou Interpreter

Packaging Specialist

Product Complaint Specialist I

Medical Logistics Specialist (D)

Medical Device Senior Regulatory Affairs Specialist

Clinical Complaint Specialist

I want to receive the latest job alert for complaint handling specialist medical device

Related Searches

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected