Quality Manager I

Under the direction of the Director of Quality or Designee, this position is responsible for:

• Provide leadership and support for Customer Focused Quality, Quality Engineering (for both Sustaining and New Product Introduction) and Quality Systems (including Supplier Quality, Documentation Center, CAPA, Training, Audits, Calibrations, Microbiology and Sterilization) improvement initiatives. Foster compliance and continuous quality improvement to meet and exceed customer expectations in a regulated environment.
• Provide Quality Engineering Management support to the development and production of Class I, II and III (as applicable) Medical Devices. Represent Quality in production process efforts, quality planning, process validations, FMEA and Risk Analysis, support new product development activities, Calibration, microbiology and sterilization activities, maintain and manage quality compliance and supplier quality management.
• Support finished goods variance investigation and resolution, complaint investigation, process improvement and quality assurance testing methodology.
• Support or lead Corrective/Preventive Action initiatives.
• Support internal / external and suppliers audit, vendor qualification and training programs.
• Participate in Quality / Business initiatives including process improvement activities, documented Quality System re-architecture and other cross-functional projects.

Main Job Duties/Responsibilities

• Support to make sure that customer requirements and Viant Quality Management System (QMS) fit and are aligned to fulfil both QMS expectations within regulated environment.
• Maintain a thorough understanding of regulations (FDA QSR) and guidelines including GMP’s, ISO 13485 and other standards applicable to the medical device industry.  
• Support sustaining manufacturing operation, Quality Assurance and Quality Systems activities.
• Establish quality programs and initiatives to ensure raw materials, components, subassemblies and finished goods are developed and manufactured according to applicable requirements.
• Support internal, external audits and supplier audits.
• Lead and mentor the direct reports to ensure quality system and external agencies requirements compliance.
• Supervise and conduct performance review of their direct reports.
• Assess effectiveness of systems with respect to all relevant regulations and requirements. Ensure consistency of systems / practices across New Product Introduction activities and their conformance to other Viant practices.
• Participate in the development of efforts to address root cause analysis and reduction of complexity of systems or processes to make them more users friendly.
• Support the implementation of internal Quality department’s initiatives.
• Responsible for providing accurate, timely, quality metrics as required by site or corporate Quality Management requirements.
• Coordinate and manage the Site CAPA Review Board to assure the relevant local, or corporate CAPA Process is implemented and effective.
• Assure compliance to any corporate Quality Systems policies and procedures to ensure compliance with the applicable domestic and international regulation/standards, as well as, Viant corporate policies.
• Serve as designee of Quality Management Representative (in absence of Quality Director) and work with the site Quality Director to assure an effective Management Review Procedure is implemented at the site.
• Lead / Assist the site in the formulation and execution of remediation efforts resulting from Compliance Inspections, FDA mock audits, Notified Body audits, Customer audits, including responses and implementation follow up.
• Lead multidisciplinary teams for problem solving initiatives originated by quality issues for either product lines or quality system.
• Responsible for developing and managing the site internal audit process, in conjunction with site quality leader.  This includes the process for planning internal audits and tracking / trending audit results, consisting of developing and monitoring audit schedules, execution of audits, review and issuance of audit report documentation and determining adequacy of corrective actions resulting from audit findings and report to Senior Management.  This will include the planning and implementation of FDA Mock audits and remediation activities.
• If required, temporary cover the QA Director Signatures / functions in case of absence.

Knowledge / Education:

• Bachelor’s degree in engineering or science (such as Pharmacy, Microbiology, Physics or Chemistry).
• Intermediate knowledge of applicable regulations for the medical device industry (FDA CFR 820 CGMPs, ISO 13485, etc.)
• Intermediate knowledge of regulatory agency requirements (for example ANVISA, JPAL, KFDA, CMDR, other) and Quality Management Systems
• Intermediate knowledge in CAPA Systems
• Intermediate knowledge in Problem Solving and Root Cause Investigation Tools
• Intermediate knowledge and application of risk management (PFMEAs)
• Intermediate knowledge in process validation, software validation, calibration and microbiology / environmental controls.
• Intermediate knowledge of statistical techniques (Gage R&R, Sampling Plans, Hypothesis Test, Statistical Process Control - SPC, Process Capability Studies, Design of Experiments - DOE).
• Intermediate use of Microsoft Office & related web applications
• Advanced bilingual English/Spanish
• Basic knowledge on Finances
• Basic knowledge of Six Sigma Methodology and Lean Manufacturing
• Knowledge in applicable safety regulations (Plus)

Job Experience: 

• At least 5 years of work experience in manufacturing environment.
• At least 5 years of experience within the medical device manufacturing, pharmaceutical fields, Engineering or Science (such as Pharmacy, Microbiology, Physics or Chemistry),
• Experience in Management is a plus