Manager, Quality Control

Topcon Healthcare • Oakland, NJ

10d • $85,000 - $105,000

About The Position

For over 90 years, Topcon’s vision has been to solve societal challenges around the globe. In healthcare, we are developing innovations that improve patients’ health and quality of life. We empower eye care providers with advanced imaging, diagnostic solutions, and intelligent data technology. Our robotic devices deliver simplicity without compromise, by capturing clear images with the push of a button. By joining Topcon Healthcare, you become part of a growing, diverse, global team. With office locations throughout North America, whether you are on-site, remote, or hybrid, our culture empowers you to contribute to company and personal success each day. At Topcon Healthcare, you can grow your career, gain new perspectives, and help address society’s most pressing challenges. If you have drive, passion, and a desire to be part of a collaborative team, we want to hear from you. At Topcon Healthcare, we don’t wait for the future. We invent it. Join us. Learn more about working with us at topconcareers.com The Manager, Quality Control is responsible for implementing processes and leading the Q uality C ontrol team, ensuring that every incoming material, in-process, and finished devices meet s rigorous regulatory and performance standards , and that nonconforming materials are handled appropriately. We are looking for an individual who possesses effective leadership and excellent organizational and communication skills, with a blend of technical knowledge and hands-on experience. This role is critical to maintain product integrity, operational excellence, and compliance with FDA Quality System Regulation, ISO 13485, and medical device requirements, while building a proactive culture of quality throughout operations.

Requirements

• Bachelor or higher degree in science or related discipline
• 5 + years of experience in Quality or a regulated manufacturing environment (medical devices, aerospace, communications, automotive, etc.)
• Familiarity with FDA QSR and ISO 13485 Requirements
• Proficiency in MS Office is
• Management experience preferred
• Ability to provide leadership to peers and drive change and improvement in quality programs throughout the organization.
• Advanced organizational skills with the ability to handle multiple assignments.
• Strong c ommunication skills (verbal and written) , and a bility to work smart in a fast-paced environment.
• Self-motivated and ability to interact with all levels of management and staff.
• Detail- o riented with s trong knowledge in creation of technical documentation.
• Ability to work independently and efficiently and work well with others.
• Ability to coordinate team activities, think proactively , and plan and execute resourcefully
• Ability to follow detailed written procedures; handle multiple tasks simultaneously and prioritize accordingly.

Nice To Haves

• Familiarity with Salesforce and ServiceMax a plus
• Familiarity with LISA a plus

Responsibilities

• G eneral management of the Quality Control department and its activities
• Supervise (and conduct if needed) quality control reviews at established inspection points and v erif y maintenance of quality control records
• Train and support Q uality Control personnel to ensure effective and competent performance of quality function s
• D etermine appropriate documentation for inspection points
• Assist with the development of receiving inspection procedures and requirements of finished product and components
• R eview and approve records for adequate point of inspection operations.
• Participate in the review of design, manufacturing, purchasing , and test documentation to ensure conformance to quality control standards. This can include review of drawings, specification sheets, production procedures, testing and inspection standards, vendor inspections and customer contract specifications.
• Review engineering change notices and related document change control , p rovide recommendations regarding facilities, equipment, personnel, procedures, and systems to carry out quality control function
• Supervise tagging and quarantine procedures for rejection of in-process, finished product, and component receiving inspection areas.
• Lead Material Review Board (MRB) activities and ensure appropriate risk-based decision making by c oordinat ing dispositions of products for rework, scrap, or return to vendor decisions C onsults and review with stakeholders as necessary.
• Assist Quality Assurance team with the processing of Supplier Corrective Action Requests. (SCAR}
• Provide statistical data to QA management for trend analysis, supplier evaluation and continual improvement initiative.
• Report serious or repeated failures or unreliability in quality of products
• Recommend corrective actions or plans/programs for overall defect reductions in products as needed.
• Manage measuring instrument calibration program and determine calibration requirements.
• Assist QA and Operations in the investigation of non-conformities, including complaints.
• Perform other related duties as .
• A ssist in other Quality Assurance tasks as .

Benefits

• Topcon offers a comprehensive benefit package for this position including medical, dental, vision, life insurance, disability insurance, tax saving spending accounts a 401(k) plan with employer match, tuition reimbursement in addition to other perks and benefits.
• We also offer time off for our employees to recharge.
• Our employees are eligible for paid company holidays, paid personal time off, and paid sick time that meets or exceeds state/local requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager