Quality Control Supervisor (Second Shift)

COMPANY DESCRIPTION


Santen is a specialized pharmaceutical company with a 130-year heritage focused exclusively on ophthalmology. With sales in over 60 countries, Santen’s 4,000 global employees work to deliver life-changing therapies that make hope a reality for people facing vision impairment and loss. Santen Inc., located in Emeryville, CA (North America HQ), contributes important research & development and commercialization efforts. This office is home to about half of our 300-total staff in North America, including our Toronto, Canada site and our recent acquisitions of Eyevance Pharmaceuticals (Fort Worth, TX) and InnFocus (Miami, FL).

We are in search of top talent to help us meet our important goals and large growth plans.

PRIMARY PURPOSE OF POSITION:

This role requires onsite work Monday-Friday on-premise at InnFocus in Miami, FL. Typical hours are 4:00 PM EST - 12:30 AM EST, Monday-Friday.

Responsible for supervising Quality Control personnel and laboratory. Collaborate with Quality and Product Development on incoming inspection of materials. Assist in defining the quality needs during the development of new products and their processes using design and development systems in accordance with FDA and international regulations. Establish and maintain systems to support the overall quality system for manufacturing of products.

MAJOR DUTIES OF POSITION:

• Supervise and coordinate activities for QC Inspectors and Technicians.
• Perform batch record review of in-process materials, components, subassemblies, and finished goods.
• Maintain inspection documentation as required from receiving to finished product release.
• Assists in maintaining the quality system for InnFocus, Inc. in compliance with ISO 13485, the U.S. Code of Federal Regulations, MDR, MDSAP, and other designated country regulations.
• Conduct testing of product as needed.
• Generate, modify as needed, and follow approved procedures such as GOPs, OPSs, QLPs, etc. for activities conducted and provide input for inspection methods and process improvements.
• Maintain working knowledge of U.S. Quality System Regulations, ISO 13485, MDR, and MDSAP.
• Maintain effective communication with supervisor and peers in daily activities.
• Ensure records i.e. test reports, evaluations, protocol reports, etc. are created and maintained in accordance with requirements of InnFocus Standard Operating Procedures.
• Apply appropriate problem-solving techniques for effective root cause analysis and successful corrective action.
• Monitor and intercede in quality system activities to assure compliance.
• Other Quality Control activities as needed in support of the quality management system

KNOWLEDGE AND SKILL REQUIREMENTS:

• Minimum four years’ manufacturing and/or quality control experience in a medical device or pharmaceutical industry, or equivalent combination of experience and education required. Experience may be substituted with a technical degree and/or an associate degree in a STEM field.
• Three years’ of supervisory experience in medical device and/or pharmaceutical manufacturing environment preferred.
• Knowledge of inspection equipment is required. As a minimum, experience with calipers, micrometers, pin gauges, microscopes, etc.
• A Certified Quality Inspector certification is a plus.

LOCATION:

• Miami, FL

COVID-19 Vaccination Requirement: Santen requires anyone working on-site or visiting company offices to confirm they are fully vaccinated against COVID-19 unless a medical or religious accommodation is timely requested and approved. Please reach out if you have questions or concerns about this policy and how it may apply to your candidacy for a role with Santen.

For more information about our company and the work experience, please visit www.santenusa.com and https://www.santenusa.com/career-culture.