Quality Technician - Caguas, Puerto Rico - TPR - Quality

Descripción

Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $5+ billion in sales, 20,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.

Job Summary

Provides technical support to Quality System operations contributing to the development of any process/tools changes to improve overall quality related to the role

Job Details/Responsibilities

Ensure compliance with all TPR procedures and all applicable regulatory agency requirements.
Support implementation of corrective and/or preventive actions that address non-conformances root causes derived from investigations.
The Quality Technician will comply with one of the assigned roles listed below:

Quality Engineering

• Notify any product or process non-conformance and escalate as appropriate.
• Execution of Quality Related Validations
• Monitoring Non-Conformance
• Performance of investigations
• Conducts and assist investigations of product issues and the gathering of information during investigations to address the nonconformance root cause analysis.
• Assist in the preparation of reports for defects trend analysis, process monitoring data (SPC) and quality summaries.
• Prepare and Execute Quality related validations (IQ, OQ, PQ, PPQ, IMV, TMV, etc.).
• Coordinates and perform applicable testing. Review and approves, as required, routine test results. Executes investigations on out of specification test results.
• Support implementation of corrective and/or preventive actions that address non-conformances root causes derived from investigations.

Compliance

• Provide support as required for FDA and ISO audits.
• Execution of quality related validations
• Monitoring Non-Conformance
• Performance of investigations
• Conduct and assist Internal Audits to the QS based on applicable regulatory agency requirements
• Gathering all required information to be deployed to the organization as part of the Quality/Compliance Metrics to be presented monthly or as required.
• Follow-up response to required, Corrective, and Preventive Actions to assure they are being followed in the manufacturing areas.

Job Responsibilities (continued)

Product Release

• Perform the review of necessary documentation and testing to ensure that manufacturing lots meet specifications and requirements for final distribution.
• Organize product release schedule to meet or exceed departmental performance standards and track against key business performance indicators.
• Coordinate the daily review of the release schedule with Planning, Operations, Quality Control, Quality Assurance and Distribution.
• Communicate effectively and coordinates tasks with Quality Control, Operations, Quality Assurance and Distribution to ensure timely release finished product.
  • Monitor the completion of documents required for batch disposition.
  • Review, track and coordinate the disposition of finished product including products with performance issues.
  • Responsible for researching, investigating, and documenting any issue delaying the product disposition with appropriate departments to ensure resolution of issues.
  • Monitor timely receipt and review of operations and laboratory records for product release.
• Perform data entry in MES, SAP systems as required.
• Prepare product certificates as required.
• Support DHR review as needed to support NCR's, Complaints, CAPA's or Audit Findings.
• Support Document Control, Change Control and Training area as required.
• Handling the request of Certificates of Conformance/Quality related to products manufactured and/or shipped from Terumo Puerto Rico LLC (TPR).

Training

• Train the manufacturing Operators and Functional Areas in applicable procedures (Manufacturing Procedures, Work Instructions etc.).
• Responsible of assuring training compliance and definition of training need of all operational personnel with the assistance of area supervisors.
• Perform Training Audits.
• Schedule and coordinate New Hire training.
• Coordinate and support all the training and cross training plan with a supervisor assuring each employee complies with the training goals.
• Conduct training certification programs with applicable procedures, following the certification checklist and test to assure the compliance of manufacturing process.
• Assist owners with providing refreshers/awareness when applicable.
• Report training failures and successes.
• Send out Periodic Review for Training Matrix/Jobs.
• Support product transfer activities.
• Generate training documentation of employees in compliance with regulatory training requirements.
• Manage the annual activity of Training Records to Document Retention. Ensure the compliance of the Quality Records.
• Ensure compliance with all TPR procedures including all applicable regulatory agency requirements.

Other duties as assigned.

Working Conditions/Physical Requirements

Knowledge, Skills and Abilities (KSA)

• Basic knowledge in CAPA (i.e., investigations), validations (IQ, OQ, PQ) and statistical techniques (Minitab).
• Proficiency level knowledge of Windows based PC and application software such as MS Office (Word, Excel (Pivot/Graphs), and Power Point), is required.
• Knowledge in Visio, and Project is preferred
• Knowledge in process monitoring tools (SPC) is preferred.
• Excellent communication skills, verbal and written.
• Must have quality mindset.
• Experience in Documentation Systems.
• Must have good verbal and written communication in English and Spanish.
• Excellent Writing and Technical Skills
• Knowledge of QSR and ISO.
• Auditing and Report writing skills is preferred.
• Must be detailed oriented, self-motivated, and able to handle multiple tasks.
• This is an onsite role. Maximum remote work: 0%
• Ability to effectively work with others is highly important.

Qualifications/ Background Experiences

• Associates Degree in Science or Technical Degree. Bachelor's degree in science is preferred.
• Experience in pharmaceutical or medical devices is required.
• Leadership experience in a manufacturing environment is preferred.
• Minimum of (3) three years of experience in regulated industry preferably with Auditor experience for Compliance Role.
• Knowledge of QSR and ISO standards.
• Knowledge and experience with Statistical Techniques and software.
• Quality related certification is preferred.

It is Terumo's policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.