A SDED Global client biotechnology company committed to developing non-evasive diagnostic tests using patent pending DNA technology is looking for a QA Lead for New Product Introduction, with extensive QMS implementation experience at existing Life Sciences companies and/or startups.
The job requirements:
* Must have at least 5+ years experience as a senior QA Lead, with an emphasis in FDA Compliance, and QMS Implementations for new product introductions at a Life Sciences company, preferable at a Medical Device company, but experience at a Pharmaceutical or a Biotechnology company will be considered.
* Self-motivated QA Lead with extensive QMS implementation experience
* Extensive experience in writing new QA specs
* Develop Standard Operating Procedures (SOPs) as required
* Develop, implement, and provide training, as needed, for QSR compliance
* Expert Validation Manager for software, cleaning, facility, utility and equipment projects
* Extensive experience in implementing, monitoring and updating quality systems
* Known as results-oriented highly intelligent individual with strong leadership, team building, and problem solving abilities to identify root cause while rapidly assimilating to new technology and processes
* Effective communicator with ability to interface, influence, negotiate and build rapport with all levels of management, subordinates, vendors, peers, clients and technical specialists
Initial contract is for 6 months, could be extended to 1 year
SDED Global works with companies that need to be FDA compliant. We provide solutions in Audits, Compliance, Software Development, Training and Validation, We accomplish this by working with client systems and remediation for any components that may be at risk. Our experts take a risk-based approach, doing what's right to ensure our clients are compliant by making certain they understand what needs to be accomplished. Our growing business has over 23 years of experience in excellence.
No man, woman or child should EVER suffer as a result of an adulterated or failed medical device. At SDED Global, it is our passion to ensure that this statement is fulfilled. SDED Global is a Medical Device Compliance Consulting firm that drives clients to excellence ensuring safe and effective medical devices domestically and internationally.
The CEO has worked in the medical device industry for 24+ years. Her education in biochemistry, began at the bench in Research/Development and led to experience in many areas of the industry from Quality to Software Development and Validation. She became integrated in what it took to confirm that a product adhered to the standards and regulations for various submissions. She thrived in this area. It is not only the goal of SDED Global, but her personal mantra, to not only adhere to but surpass global regulations and standards.
At SDED Global, we evaluate Client needs and customize the required strategy and solution to provide high Quality Compliance Consulting that is Efficient, Innovative, Analytical, Deliverable and first to market. We offer the best customer experience and empower our clients with skill sets to maintain a defend-able product. We not only meet their immediate needs we teach and guide all throughout the processes. This approach allows us to demonstrate what is required to sustain their long-term goals.
Role: Quality Affairs Lead for New Product Introduction
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