Job Summary
Role Overview:
As a quality leader, you will be responsible for providing strategic direction and governance to ensure the effectiveness of our Quality Management System.
This role involves managing multiple concurrent projects to maintain regulatory compliance throughout the product development lifecycle.
The successful candidate will play a critical part in ensuring product quality and patient safety by executing quality processes effectively.
You will lead efforts to enhance the supply chain by addressing supplier and customer issues, improving quality processes internally and with suppliers, and executing quality strategies.
1. Lead project planning activity and develop comprehensive project plans including scope, timelines, budget, resources, and project success criteria.
2. Gain buy-in from project team and ensure an inclusive approach to project planning.
3. Proactively identify gaps and risks to project success and implement mitigation strategies to minimize impact.
4. Collaborate with cross-functional teams, internal and external to the organization, to coordinate project execution and ensure that project objectives and success criteria are met.
5. Provide Quality direction to multiple concurrent product development programs to ensure product and process compliance to all applicable regulatory and cGMP requirements.
6. Author, review, and/or approve design history documentation and design manufacturing documentation (e.g., product specifications, design verification and validation activities, FMEA risk documents, test methods, protocols, reports, manufacturing batch record reviews, etc.).
7. Support the development and maintenance of product or process risk and hazard analysis in accordance with organizational policies and procedures and ISO standards.
Key Responsibilities
Project Planning and Execution:
Develop and execute comprehensive project plans, ensuring timely completion and adherence to budget and resource allocations.
Quality Leadership:
Provide strategic direction and governance to ensure the effectiveness of the Quality Management System.
Supply Chain Enhancement:
Lead efforts to improve the supply chain by addressing supplier and customer issues, enhancing quality processes, and executing quality strategies.
Regulatory Compliance:
Maintain regulatory compliance throughout the product development lifecycle, ensuring product and process compliance to all applicable regulatory and cGMP requirements.
Requirements
* Bachelor's Degree in Engineering or Science or equivalent experience required.
* Minimum 5 years of experience in a regulated industry (e.g., Medical Device), including Product Manufacturing and Post Market Surveillance Activities required.
* Demonstrated experience (4+ years) independently defining, planning, and executing projects in highly regulated environments with a track record of success required.
* In-depth knowledge of cGMP regulations, ISO 15378 or ISO 13485, 21 CFR 820, ISO 14971 required.
Preferred Qualifications
* Experience with MasterControl, SAP, Share Point.
* Experience with ISO 11040, ISO 11607.
* Expertise in quality management tools. Standards, policies, and procedures – APQP, PPAP, MSA, SQC etc
* Strong working knowledge of quality systems of the respective ISO norms
Additional Requirements
* Exhibit a strong commitment to quality and patient safety.
* Ability to work effectively in a fast-paced environment with multiple priorities and deadlines.