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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.
Contract positions
Will be employed and paid hourly by iMPact Business Group. Benefits (medical, dental & vision) are available after 90 days of employment.
Permanent placed employees
Paid by and qualify for benefits in accordance with the policies of the hiring company.
Submit your resume today to be considered for this position. A recruiter will review within a business day or two and will reach back out to you if they would like to discuss next steps.
Internal Positions
We have several internal positions at iMPact that we are hiring for. Please view our internal positions here.
- Recruiters
- Account Managers
Learn more about working with iMPact Business Group
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