Branch Medical Group · 6 hours ago
Quality Control Supervisor
Eagleville, PA
Full-time
Onsite
Mid, Senior Level
4+ years expGlobus Medical is a company that manufactures a wide range of implants for spinal and orthopedic applications. The Quality Control Supervisor is responsible for overseeing floor operations related to Quality Control, ensuring compliance with FDA regulations and ISO standards, and managing a team of QC Inspectors to maintain quality assurance policies and procedures.
Health CareManufacturingMedicalMedical Device
Responsibilities
Direct and supervises the Quality inspection functions within the manufacturing facility
Supervises the activities of employees in Quality and ensures compliance to procedures
Ensures purchased materials and manufactured products conform to specifications and quality standards
Confers with purchasing, customers, and vendors regarding specifications, errors, problems, complaints, compliance with government regulations, international standards and company requirements
Oversees quality control inspections on incoming materials and manufactured products
Manages and dispositions non-conforming material as part of MRB
Provides resources to addressing customer complaint investigations
Performs annual performance assessments of direct reports
Assists with equipment qualification on new inspection equipment
Assists Manufacturing and Engineering in implementation of new procedures, equipment, and methods as related to quality of product and cost reduction
Assists Manufacturing, and Engineering in identifying quality requirements and problems for the improvement and establishment of new and existing products, procedures, processes and methods
Provides resources for periodic vendor and internal audits to ensure system conformance, effectiveness and accuracy
Identifies, develops, and provides training for Quality Assurance staff, for Production Planning and Control, and Manufacturing as needed, as related to Quality Control norms
Provides support and expertise in the implementation and enforcement of ISO 13485, ISO 14971 and FDA Quality System Regulation
Communicates and support facility quality objectives
Helps to establish, follow, and improve company procedures
Provides written and oral reports to others to keep them informed of activities and results
Maintains a cooperative and motivational attitude with co-workers
Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies
Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties
Qualification
Required
Strongly prefer education level of bachelors' degree (science or engineering preferred) with a minimum experience of as follows
Minimum 2 years of experience leading others
Minimum 2 years inspection experience in a manufacturing environment in Quality Control or Quality Assurance roles with GMP and SOP's to ISO standards. Preferring that inspection experience to be with a manufacturer of medical devices or similar environment of small lot CNC machining, 3D printing, various assembly and finishing processes
4 years related experience in another manufacturing and FDA-regulated sector
Or education level of Masters with 2 years related experience
Computer proficiency with MS Office and statistical analysis tools is required
Solid knowledge of statistical process control theory, application, and calculation is required
Ability to use standard measuring equipment (i.e. Micrometers, Calipers, Height Gages, profilometer, ring, plug and thread, go no/go gages, dial indicator, surface plate, gage blocks and torque wrench) is required
Ability to read and interpret engineering drawings for medical devices, including Geometric Dimensioning and Tolerancing (GD&T) is required
Attention to detail
Self-starter
Advanced critical thinking and problems-solving skills
Preferred
Automated inspection system experience is a plus
Company
Branch Medical Group
Branch Medical Group is manufactures medical implants and graphic cases.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
unknown2015-02-25Acquired
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