Overview
On Site
USD 50.00 - 65.00 per hour
Full Time
Skills
MI
Marketing Intelligence
Quality Control
Clinical Research
Testing
Auditing
Supervision
Surveillance
Regulatory Compliance
Acquisition
System Integration
Issue Resolution
ROOT
Collaboration
Documentation
Trend Analysis
Continuous Improvement
QMS
ISO 9000
ISO/IEC 27001:2005
TL 9000
Life Sciences
Quality Assurance
Medical Devices
Pharmaceutics
ISO 13485
Corrective And Preventive Action
Management
Problem Solving
Conflict Resolution
Data Analysis
Communication
Innovation
Quality Management
Privacy
Marketing
Job Details
Location: Portage, MI
Salary: $50.00 USD Hourly - $65.00 USD Hourly
Description: Our client is currently seeking a Specialist, Quality Assurance for a 12 month + contract.
Implement quality standards, ensure and execute compliance on every stage of the process. Assess potential risks, ensures compliance and gives recommendations. Takes responsibility for all quality control aspects of the process (laboratories studies, clinical research, testing, operations, raw materials, production, finished product or services). Facilitates audits and regulatory inspections. Coordinates quality trainings. This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires the ability to make judgements based on practice and previous experience. This job typically requires a degree or equivalent and no experience.
Senior Quality Assurance Engineer We are seeking a dedicated Senior Quality Assurance Engineer with strong Quality System experience to join our integration team. In this role, you will support post-market surveillance, complaint handling, and continuous improvement activities while ensuring compliance with regulatory requirements. As part of a recent acquisition of a software technology company, this individual will support activities to integrate this new business with an existing medical device quality system. Experience with software products and non-medical devices is preferred to assist in the post-market assessment activities and quality system integration.
Key Responsibilities:
Complaint Management and Issue Resolution:
o Manage and analyze customer complaints, warranty claims, and field failures to identify root causes, drive effective corrective actions, and improve product reliability.
o Support the development and assessment of product return process as part of complaint handling. o Collaborate with cross-functional teams to ensure timely closure and documentation of complaints.
o Develop and deliver regular trend analyses and reports to identify systemic issues and areas for improvement.
Quality System Management:
o Support the maintenance and continuous improvement of the Quality Management System (QMS) in alignment with industry standards (e.g., ISO 9001, ISO 27001, TL 9000).
o Create, review, and update quality procedures, work instructions, and best practices.
o Consult with various Post Market stakeholders to create and propose process maps that may be used as part of procedure creation.
Qualifications:
o Bachelor's degree in Engineering, Life Sciences, or related field (or equivalent experience).
o 3+ years of experience in Quality Engineering within the medical device, pharmaceutical, or related regulated industry.
o Strong knowledge of quality system regulations (ISO 13485, 21 CFR Part 820)
o Experience with complaint handling, CAPA, and nonconformance management.
o Excellent problem-solving, data analysis, and communication skills.
This contractor role offers the opportunity to play a vital part in our organization's growth and innovation, ensuring a seamless and compliant integration of Quality Systems across both companies.
By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes. Message & data rates apply and message frequency may vary. Consistent with Judge's Privacy Policy, information obtained from your consent will not be shared with third parties for marketing/promotional purposes. Reply STOP to opt out of receiving telephone calls and text messages from Judge and HELP for help.
Contact:
This job and many more are available through The Judge Group. Please apply with us today!
Salary: $50.00 USD Hourly - $65.00 USD Hourly
Description: Our client is currently seeking a Specialist, Quality Assurance for a 12 month + contract.
Implement quality standards, ensure and execute compliance on every stage of the process. Assess potential risks, ensures compliance and gives recommendations. Takes responsibility for all quality control aspects of the process (laboratories studies, clinical research, testing, operations, raw materials, production, finished product or services). Facilitates audits and regulatory inspections. Coordinates quality trainings. This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires the ability to make judgements based on practice and previous experience. This job typically requires a degree or equivalent and no experience.
Senior Quality Assurance Engineer We are seeking a dedicated Senior Quality Assurance Engineer with strong Quality System experience to join our integration team. In this role, you will support post-market surveillance, complaint handling, and continuous improvement activities while ensuring compliance with regulatory requirements. As part of a recent acquisition of a software technology company, this individual will support activities to integrate this new business with an existing medical device quality system. Experience with software products and non-medical devices is preferred to assist in the post-market assessment activities and quality system integration.
Key Responsibilities:
Complaint Management and Issue Resolution:
o Manage and analyze customer complaints, warranty claims, and field failures to identify root causes, drive effective corrective actions, and improve product reliability.
o Support the development and assessment of product return process as part of complaint handling. o Collaborate with cross-functional teams to ensure timely closure and documentation of complaints.
o Develop and deliver regular trend analyses and reports to identify systemic issues and areas for improvement.
Quality System Management:
o Support the maintenance and continuous improvement of the Quality Management System (QMS) in alignment with industry standards (e.g., ISO 9001, ISO 27001, TL 9000).
o Create, review, and update quality procedures, work instructions, and best practices.
o Consult with various Post Market stakeholders to create and propose process maps that may be used as part of procedure creation.
Qualifications:
o Bachelor's degree in Engineering, Life Sciences, or related field (or equivalent experience).
o 3+ years of experience in Quality Engineering within the medical device, pharmaceutical, or related regulated industry.
o Strong knowledge of quality system regulations (ISO 13485, 21 CFR Part 820)
o Experience with complaint handling, CAPA, and nonconformance management.
o Excellent problem-solving, data analysis, and communication skills.
This contractor role offers the opportunity to play a vital part in our organization's growth and innovation, ensuring a seamless and compliant integration of Quality Systems across both companies.
By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes. Message & data rates apply and message frequency may vary. Consistent with Judge's Privacy Policy, information obtained from your consent will not be shared with third parties for marketing/promotional purposes. Reply STOP to opt out of receiving telephone calls and text messages from Judge and HELP for help.
Contact:
This job and many more are available through The Judge Group. Please apply with us today!
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.