Molding _ Quality Manager at Viant

, , Costa Rica -

Full Time

Start Date

Immediate

Expiry Date

18 Apr, 26

Salary

0.0

Posted On

18 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management, Quality Engineering, Regulatory Compliance, Root Cause Analysis, Process Validation, Statistical Techniques, CAPA Systems, Team Leadership, Interpersonal Skills, Problem Solving, Risk Management, Auditing, Training, Microbiology, Lean Manufacturing, Six Sigma

Industry

Medical Equipment Manufacturing

Description

This is a full-time position to work Monday to Friday 8am to 5pm in our Heredia site located in Zona Franca Metropolitana. Remote work might be allowed based on business needs. Under the direction of the Director of Quality or Designee, our Molding Quality Managers are 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 QMSR) 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 Intermediate 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 Certified Quality Engineer (CQE), Certified Quality Manager (CMQ), Certified Six Sigma Black Belt (CSSBB) is a plus. Knowledge in applicable safety regulations is a 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 Skills / Competencies Interpersonal skills and ability to communicate orally and in writing, with individuals or groups. Self-motivated. Passionate. Organized and able to manage multiple tasks and priorities. Able to quickly and independently make decisions. Highest ethical standards and professional integrity. Teamwork oriented. Hands-on, collaborative, decisive. Self-starter willing to take calculated risks. Effective presentation skills and able to deliver insightful messages to external and internal audiences. Demonstrated leadership and motivational skills. Negotiation skills Coaching and/or mentoring skills Decisions influencer Physical / Licenses Requirements: Office position with travel if needed. No unusual or excessive physical demands. Passport Required Able to travel inside and outside the country if needed. Viant is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life enhancing medical devices. We do this through our depth and breadth of capabilities, end-to-end integration, technical expertise, and relentless focus on our customers and on operational excellence. With nearly 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources. For more information, visit viantmedical.com or follow us on LinkedIn. Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.

Responsibilities

The Molding Quality Manager is responsible for leading quality initiatives and ensuring compliance with regulations in the medical device manufacturing environment. They will support quality engineering management and oversee quality assurance testing and process improvements.