Quality - Quality Compliance Supervisor

Viant•Vega Baja, PR

1d•Onsite

About The Position

We’re a company of agile, customer-oriented individuals with a shared commitment to integrity, servant leadership, and teamwork. Our associates take pride and ownership in their work, and innovate to provide the highest quality, life-enhancing medical technology in the world. Together, We’re in It for Life. JOB SUMMARY: Supervise and lead Document Control Team Member in day to day administration actives of key quality system processes such as; overall documentation support, change control, training, CAPA, complaint processes, internal/external audits support, environmental control and Quality Management Review. Directs implementation and management of cleanroom and sterilization validation, microbiological analysis, and environmental control at the direction of the Quality Director for site activities. Responsible for continuous review of FDA regulations, ISO standards, quality assurance philosophy, practices, and procedures to recommend compliant procedures and cost-effective solutions. Establishes and ensures maintenance of training programs for quality control personnel in regards to sterilization and environmental control. The position requires providing technical guidance for evaluating and assessing compliance to customer requirements.

Requirements

BS/BA in Sciences, Microbiology or Technical Discipline or equivalent experience
Certified Lead Auditor
Knowledge of FDA 21 CFR 820 QSR, ISO13485 Medical Device Standard, 21 CFR Part 4 Combination Products, 21CFR Part 11 Electronic Records and Signature, and ISO14971 Risk Assessment
3-5 years of experience in the quality or regulatory field
3 years or experience administering Quality System processes described above.
Experience in medical device, combination products or related regulated industry
Working knowledge of internal and external auditing functions
Working knowledge of CAPA programs
Excellent communication skills
Able to interface with customers on technical/compliance issues
Able to work both independently and in a team-based environment
Knowledge of Microsoft Office Suite (Word, Excel, PowerPoint,), Master Control and IQMS (ERP System).

Responsibilities

Ensure the effectiveness implementation of the Plant Quality Management System, ensure document control system is effectively implemented
Support the administration of Master Control for the specified plant location. This includes, but is not limited to, the addition of new users to the system, role assignment or changes to role assignments; provide training to new users as it relates to their assigned roles.
Ensure that the document control system is compliant with applicable FDA regulations, ISO standards; company SOPs, and Customer requirements.
CAPA System Administration including CRB meeting coordination, report generation and communicating updates to the plant CAPA Board.
Support the administration of the Training Module in Master Control; this work is to be done in collaboration with site’s HR.
Ensure all quality system documents are properly created, reviewed, approved and retrievable; traceability that includes current and obsolete documents.
Audit preparation and support – Coordinate the internal audit program to assure audit are completed on time, and appropriate actions are taken and complete as a result of the audit responds. Support external audits, as appropriate.
Support the management review process with quality system updates from internal audits, corrective action and customer complaints. Working with Quality Management Representative, help organize, prepare and present Quality Management Reviews.
Support administration of the Customer Complaint Process to assure complaints are properly documented and assigned.
Support and assure proper administration of the document control process, including change control and training related to documentation updates.
Collaborate with Site HR to assure proper job code are in place for each position and properly link to documentation for training purposes.
Write protocols and reports for Sterilization and/or Microbiological Validation, completes associated paperwork to ensure proper execution (protocol checklists, laboratory submission forms, etc.), interacts with customers as needed
Support microbiology testing for sterility and endotoxin testing.
Develop, implement and assure continuance of microbiological testing programs for all critical materials used in engineering, manufacturing and sterile products.
Develop written procedures to control routine sterilization processing.
Establishes and ensures compliance with good housekeeping practices, employee hygiene, and equipment sanitation.
Implement various testing programs to assure all materials, the manufacturing environment, environmental control systems and finished products meet all regulatory requirements, including GMP and ISO for sterility and pyrogenicity
Coordinate and perform internal audit and audit to contract sterilizers and testing laboratories.
Direct, evaluate, monitor and review controlled environment microbiological control methods and programs.
Develop action plans to resolve environmental controlled issues that have the potential to impact product quality.
Track and trend laboratory errors and resulting corrective action commitments.
Assist and participate in internal, customer, ISO and/or FDA audits/Inspections.
Coordinate and collect environmental controlled data for site clean rooms.
Other related duties.