Quality Control Supervisor

Branch Medical Group•Eagleville, PA

1d•Onsite

About The Position

The Quality Control Supervisor is responsible for floor operations, specifically Quality Control, and is also a caretaker of sitewide adherence and continual improvement of company programmatic Quality Assurance policies and procedures. This role directly oversees a staff of hourly QC Inspectors (Level I, II, and Senior) and works with every department to ensure maintaining compliance with US FDA and international medical device regulations and ISO 13485 quality system requirements. Branch Medical Group, a subsidiary of Globus Medical Inc., manufactures a wide range of implants for spinal and orthopedic applications as well as designs instrumentation cases. The company is passionate about improving patient care and understands that speed is critical.

Requirements

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.
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

Nice To Haves

Education level of bachelors’ degree (science or engineering preferred)
Inspection experience 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.
Masters degree with 2 years related experience.
Automated inspection system experience is a plus.

Responsibilities

Direct and supervise the Quality inspection functions within the manufacturing facility.
Supervise the activities of employees in Quality and ensure compliance to procedures.
Ensure purchased materials and manufactured products conform to specifications and quality standards.
Confer with purchasing, customers, and vendors regarding specifications, errors, problems, complaints, compliance with government regulations, international standards and company requirements.
Oversee quality control inspections on incoming materials and manufactured products.
Manage and disposition non-conforming material as part of MRB.
Provide resources to address customer complaint investigations.
Perform annual performance assessments of direct reports.
Assist with equipment qualification on new inspection equipment.
Assist Manufacturing and Engineering in implementation of new procedures, equipment, and methods as related to quality of product and cost reduction.
Assist Manufacturing and Engineering in identifying quality requirements and problems for the improvement and establishment of new and existing products, procedures, processes and methods.
Provide resources for periodic vendor and internal audits to ensure system conformance, effectiveness and accuracy.
Identify, develop, and provide training for Quality Assurance staff, for Production Planning and Control, and Manufacturing as needed, as related to Quality Control norms.
Provide support and expertise in the implementation and enforcement of ISO 13485, ISO 14971 and FDA Quality System Regulation.
Communicate and support facility quality objectives.
Help to establish, follow, and improve company procedures.
Provide written and oral reports to others to keep them informed of activities and results.
Maintain a cooperative and motivational attitude with co-workers.
Adhere to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.
Ensure 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.
Represent 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.