Website Talent Wave Associates, LLC
Talent Wave Associates, LLC
Company : Talent Wave Associates, LLC
Are you ready to elevate quality standards and drive innovation in the medical device industry?
Our client is seeking a dynamic professional to provide pivotal quality engineering and technical support across various departments, including Operations, Sustaining Engineering, R&D, and New Product Introductions. This role involves ensuring compliance with quality standards through activities such as Change Control, Design Control, and Post Market Surveillance.
- Review and manage change requests, impacting product design and documentation.
- Evaluate and ensure technical accuracy and compliance of documentation.
- Drive quality initiatives to enhance compliance and operational efficiency.
- Lead corrective and preventive actions to address product non-conformances.
- Support risk management activities and regulatory inspections.
- Ensure adherence to regulations for electromechanical and non-EMD medical devices.
Minimum Requirements:
- Bachelor's degree in Physical Science or Engineering, or equivalent experience.
- 3-5 years in a quality engineering role.
- 6-7 years in the medical device or pharmaceutical industry.
Preferred Qualifications:
- Experience with electromechanical devices.
- ASQ Certification as a Quality Engineer or equivalent.
Technical & Functional Skills:
- Expertise in quality requirements for medical devices/pharmaceuticals.
- Strong technical writing and problem-solving skills.
- Proficiency in Microsoft Office Suite and Quality System Management Software.
- Familiarity with ISO 13485, FDA regulations, GMPs, and international standards.
- Effective communication and ability to manage multiple priorities.
This is an onsite position with a 6-month contract to hire opportunity.
At Talent Wave Associates, we connect outstanding talent with exceptional opportunities. We're proud to be an Equal Opportunity Employer and are committed to fostering an inclusive, people-first recruiting experience. Ready to ride the wave of opportunity? Apply today!
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