Senior Quality Assurance Manager

Job Summary :

The Senior Quality Assurance Manager plays a pivotal role in overseeing Quality and Compliance activities at Highridge Medical. You will provide strategic and technical guidance to our Quality Assurance, Calibration, Quality Engineering, and Supplier Quality Engineering teams. Your primary focus will be ensuring that our production processes meet all regulatory standards while guaranteeing that our medical devices adhere to established quality benchmarks through precise inspection and testing of both raw materials and finished products. You will lead our efforts in Supplier Quality Management, Production and Process Controls, Product Release, Nonconforming Products, CAPA, and audit management, while effectively allocating resources to ensure timely and budget-friendly quality initiatives.

Principal Duties and Responsibilities :

• Oversee all supplier quality activities, including qualifications, performance monitoring, SCARs, and audits.
• Develop and manage procedures, specifications, and standards for product quality control, incorporating methods such as non-destructive testing and inspections.
• Coordinate the calibration program for all inspection tools and gauges to ensure compliance with company protocols.
• Establish and maintain robust data collection and reporting systems to adhere to regulatory demands and promote continuous improvement.
• Manage nonconforming products, ensuring appropriate corrective actions are taken and escalated to CAPA or SCAR as needed.
• Employ defect prevention strategies utilizing SPC / SQC principles to enhance product quality.
• Maintain quality systems while overseeing audits and inspections, including those from the FDA and Notified Bodies.
• Ensure a smooth design transfer process is executed, preparing both suppliers and teams for the integration of new designs while monitoring quality throughout.

This is not an exhaustive list of duties or functions and may not encompass all essential functions for purposes of the ADA.

Expected Areas of Competence (i.e., knowledge, skills, and abilities)

• Thorough understanding of supplier quality management requirements and techniques.
• Expertise in inspection methods and test method validation.
• Able to collaborate and communicate effectively across teams within and beyond the Quality department.
• Skilled at leveraging organizational resources to drive results.
• Results-oriented mindset with a strong ability to meet deadlines.
• Solid grounding in statistical methods, process control, and capability techniques.
• Exceptional communication skills.
• Proven leadership experience in directing and developing a professional team.
• Ability to interpret engineering drawings and specifications.
• Familiarity with relevant regulatory standards such as Quality System Regulation, MDSAP, and ISO 13485.

Education / Experience Requirements

• A Bachelor's Degree in engineering with 6-8 years of quality function experience, or an advanced degree in engineering with 4-6 years of relevant experience.
• Quality discipline certification preferred (e.g., CSQP, CQE, CMQ / OE).
• Experience in quality control methods including non-destructive testing, metrology, and statistical process control.
• Experience interacting with regulatory agencies, such as the FDA.
• Lead Auditor Certification is a plus.
• A minimum of 2 years of experience in a management role is required.

Travel Requirements

Up to 10%