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iMPact Business Group
https://cdn.haleymarketing.com/templates/62439/images/impact-200x200.png
http://www.impactbusinessgroup.com
http://www.impactbusinessgroup.com
USD
80000.00
95000.00
YEAR
true
Quality Engineer
Posted: 01/05/2024
2024-01-05
2024-03-20
Job Type:
Permanent/Direct Hire
Industry: Engineering
Job Number: 24729
Pay Rate: $ 80000.00 - $ 95000.00
Job Description
Our client, a leading player in the healthcare/medical device manufacturing industry, is seeking a talented Quality Engineer to play a key role in launching and sustaining the production of Medical Devices. If you're ready to make a difference and contribute to a team dedicated to excellence, we want to hear from you!
Responsibilities:
Responsibilities:
- Follow and comply with FDA Quality Systems Regulations, ISO Standards, and SOPs as defined by Viant Medical's policies and procedures.
- Continuously review methods, procedures, and processes to identify opportunities for improvement in quality and cost, leading initiatives to reduce scrap and increase efficiencies.
- Independently lead problem-solving efforts, including customer complaint investigations and analysis, to ensure timely resolution of quality issues.
- Assist in writing nonconformance reports and provide feedback and recommendations for improvement.
- Initiate and contribute to the development of essential documents for product launches, including Master Validation Plans, Test Method Validations, and inspection protocols.
- Participate in IQ/OQ/PQ/PV activities, risk analysis, and validation of production processes.
- Conduct machine and process capability studies, recommend changes to improve product quality, and assess compliance with applicable regulations.
- Train Quality Assurance Inspectors and manufacturing personnel on specifications, procedures, and environmental controls.
- Lead or participate in internal/external Quality System audits.
- Assess the Supplier Development Program, address problems, and recommend solutions to ensure product specifications are met.
- Review potential changes to products in production for reliability impact and aid in the correction process.
- Maintain effective working relationships with all departments.
Job Requirements
Qualifications:
- BS in Engineering, Science, or related field, or equivalent experience and training.
- Knowledge of FDA QSR, ISO13485, and ISO14971 Risk Assessment is desirable.
- 3-5 years of relevant Quality Engineering experience.
- Experience in Medical Device, Healthcare, or Pharmaceutical industries is preferred, but not required.
- Experience in Customer-Focused Quality and/or Business Process Improvement.
- Project Management skills.
- Lean Manufacturing experience.
- Working knowledge of statistical techniques.
- Working knowledge of quality and reliability software.
- Ability to work effectively in a team environment.
Preferences:
- Passion for continuous improvement and innovation.
- Strong communication and interpersonal skills.
- Detail-oriented with a focus on results.
- Ability to thrive in a dynamic and fast-paced environment.
Ready to Make a Difference?
If you are excited about contributing to the healthcare industry's advancement and possess the skills and experience outlined above, we invite you to apply. Join our team and play a vital role in ensuring the quality and safety of medical devices that impact lives every day.
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