Pacific Instruments, Inc. · 2 hours ago
Quality Control Manager
Honolulu, HI
Full-time
Onsite
Mid, Senior Level
$80K/yr - $100K/yr
2+ years expPacific Instruments is a contract manufacturer and global procurement partner specializing in orthopedic surgical instruments. The Quality Control Manager oversees and has ultimate responsibility for the quality control aspects of medical devices, ensuring compliance and efficiency in processes.
ManufacturingMedical DeviceWholesale
Responsibilities
Supervise the quality control, quality engineering, and inspection personnel by managing their duties, training, and responsibilities
Collaborate with customer service, logistics, purchasing, product development engineering, quality assurance, and executive management to ensure customer requirements are met and to achieve desired business results
Oversee quality control operations including inspection, acceptance activities, equipment calibration, record maintenance, and nonconformance handling
Develop, plan, monitor, and analyze key metrics and goals for the day-to-day performance of quality control team to ensure efficient and timely completion of tasks
Participate in performance reviews, including development plans, for personnel under their supervision
Develop, implement, and monitor day-to-day quality control processes that provide visibility into goals, progress, and obstacles for Pacific Instruments’ key milestones
Identify and implement process improvements that will maximize output and minimize costs
Manage customer and supply chain quality issues
Uphold and adhere to Pacific Instruments’ Quality Policy
Challenge and continuously improve the existing Company Quality System by ensuring processes are current, seeking opportunities for improvement, and developing new efficient procedures
Maintain professionalism within the office and with all contacts outside the office such as customers, suppliers, marketers, and/or third-party persons
Maintain a clean and safe work area
Be self-motivated person and handle all items with clean hands and care
Other duties as required by the President
Responsible for the management of: review of the purchase order routers for potential quality control issues, creation and approval of product inspection routers and dimensional datasheets for Device Master Record, review of documentation from suppliers and request supplemental information as needed (i.e., missing certifications, work orders, etc.), generation/review/approval of Pacific Instruments Certificate of Conformance and supporting documents that need to be included with shipments to the customer, final review and approval of instruments, labeling, and documentation for the release of finished goods, product investigations related to complaints and non-conformances for both customers and suppliers, maintenance of product Device History Records
Qualification
Required
2 years minimum experience as a quality manager, preferably within the medical device industry
Knowledge of multiple operational functions and principles, including quality control, quality assurance, production, and employee management
Ability to plan and manage technical operational quality control process for maximum efficiency and productivity
Ability to streamline and implement new structures and roles that create speed, efficiency, and support rapidly shifting business demands
Excellent organizational and time management skills
Ability to work well with team members in a fast-paced environment. Must have a 'can-do' attitude and be comfortable working in a small, flexible, and dynamic team
Ability to understand recordkeeping and be accurate and precise
Preferred
Bachelor's degree in mechanical, electrical, or biomedical engineering preferred
ISO 13485:2016 certification and GMP knowledge preferred
Company
Pacific Instruments, Inc.
Pacific Instruments is a globally recognized OEM manufacturer specializing in the management, design, development, and manufacture of complex, high-quality German instrumentation.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase