Process Quality Manager

About the Role

We are looking for a dynamic and detail-oriented Senior Executive – Electronics Sourcing with 4 to 5 years of experience in medical equipment manufacturing. The candidate will be responsible for sourcing electronic components, managing suppliers, and ensuring timely availability of materials required for production, while maintaining high standards of quality and compliance.

Quality Control Manager

Reports to: VP

Department: SSi Production Center

Product line: Mantra/Mudra

Key Responsibilities:

• Work in a fast-paced, cross-functional, rapidly growing start-up environment.
• Manage and investigate production quality and compliance issues reported from the field, develop team and processes to analyze results, determine root cause and review reports
• Partners with cross-functional teams to manage investigations for complex product/ manufacturing issues. Develop team to perform experiments and tests for complex issues (including writing and executing protocols).
• Lead team to manage escalation tasks and activities, including Risk Assessments (RAs) and Corrective/Preventive action(s) (CAPAs) as determined by investigation.
• Manage and support projects to ensure adequate supply and maintain business continuity, including ongoing design verification activities
• Support and maintain risk management files in compliance to appropriate external standards and corporate policy
• Identify opportunities and lead the implementation of changes to drive improvements
• Manage and develop professionals/engineers and oversee the work of assigned quality team within own area and/or projects. Drive quality culture, engage staff morale, and ensure employees' safety.
• Manage quality project activities with the accountability for successful completion of all deliverables to the business within established schedule, scope and quality objectives. Identify risk, develop mitigation strategies, alternative solutions, resolve issues, etc. in collaboration with cross functional groups.
• Oversee engineering tasks; provide technical guidance and feedback to technicians/engineers; guide junior associates on more complex procedures
• Ensure quality management system requirements are effectively established and maintained, and that production lines operate in a state of compliance and inspection readiness.
• Work with corporate quality department to ensure quality policies are effectively maintained.
• Anticipate/mitigate regulatory and quality risks within area of responsibility.

Qualification Requirements

• Bachelor's Degree in Engineering or related field required with 8+ years of experience in medical device manufacturing. Master's Degree may offset some required experience.
• People management experience required - including providing coaching and feedback, responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations.
• Quality Management experience in a regulated medical device or life sciences industry preferred.

Required Skills:

• Ability to derive CTQ’s for both electronic and mechanical components and establish inspection criterion for electro-mechanical assemblies.
• Advanced understanding and professional experience in root cause analysis, statistical methods, risk management, design of experiments, process validation, and lean manufacturing
• Deep Knowledge in applicable Medical Device Quality regulatory requirements
• Experience in design and implementing quality improvement processes in support of business plans - cross functional projects with R&D, Operations, and Manufacturing Engineering organizations.
• Demonstrates high level problem-solving, analytical and critical thinking skills including high discretion/judgment in decision making
• Professional communication and interpersonal relationship skills including developing and managing cross functional relationships management and ability to drive achievement of objectives
• Thrives in a dynamic, fast paced, results oriented environment
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Strict attention to detail