Job Title
We are seeking a strategic quality assurance leader to spearhead our organization's new product introduction efforts. This role will oversee the execution of quality strategies for launching innovative products, focusing on speed-to-market, risk mitigation, and regulatory compliance.
This position requires a passion for excellence, innovation, and people development, with expertise in enabling technology platforms and cutting-edge supply chain solutions. The ideal candidate will have a strong focus on process risk management, including robust pFMEA to deliver high-quality products at launch.
In this leadership role, you will:
* Lead the QA team in partnering to drive preventative measures and improvements of product quality and process design.
* Drive the execution of new product development strategy, promoting highly capable processes that result in high yield and enable scalability.
* Build organizational capability by promoting the optimization of inspection strategies for launch through technology, automation, and supplier certification.
* Inspire others by coaching and developing staff who champion quality assurance during the product development process.
* Deliver results by ensuring appropriate production and process controls are identified, qualified, and implemented throughout the manufacturing process.
The successful candidate will possess:
* A Bachelor's Degree in Engineering or Science discipline, or equivalent.
* Business Management or MBA is an added advantage.
* Minimum 10+ years' experience in a Medical, Pharmaceutical, Bio-Medical/Pharma, Automotive, or regulated manufacturing environment.
* Minimum 6+ years' experience and a proven track record of successfully creating and managing a highly talented, engaged, and performing team.
Responsibilities include leading regional NPI Quality initiatives, driving quality-related activities, and overseeing the development of lean inspection strategies. Additionally, you will be responsible for fostering collaborative internal/external professional relationships and communicating effectively with stakeholders.
We seek a motivated and experienced quality assurance leader who can inspire others and make timely decisions. If you are passionate about quality and have a proven track record of success, we invite you to apply for this challenging role.
Key Skills:
* Regulatory requirements, standards, and regulations
* SPC / Process Control, FMEA, Problem Solving / Root Cause Analysis, Poka-Yoke, Six Sigma tools
* Leadership ability to develop and implement organizational strategy
* Initiative, sponsorship, and implementation of change
* Ability to work in a team and individual environment