Quality Site Lead - West Valley City - job 636609

Company Description

The Quality Site Lead will be a valued member of the Maxtec, LLC leadership team and will play a key role in enabling the future growth plans of the company.

Job Description

As the Quality Site Lead, you will ensure the safety and efficacy of our products  by serving as the primary Quality leader of the site. You will ensure company compliance with all elements of the quality management system at the site ensuring processes are established and maintained in accordance with company policies and regulatory requirements to support the design, and manufacturing of Class I and Class II (per the United States FDA Classification) devices.

Leadership

• Formal Management Representative responsible for the maintenance of Quality Management System including the EN ISO 13485:2016 certifications through the MDSAP program.


• Provide Quality oversight and leadership across site working in partnership with other functions including Regulatory Affairs, Operations, Source, Supply Chain, Finance, HR etc.


• Execute to the approved Quality strategy and strategic initiatives. Effectively influence and mobilize key stakeholders toward desired results and future-state.


• Strongly influence and mobilize key stakeholders around the Quality vision and strategy, by engaging cross functional leaders.


• Deployment of strategic and quality objectives

Continuous Improvement

• Generates innovative solutions and calculated vital actions for Quality Operations to achieve rapid improvement, sustainable results, and cost management.


• Establish and maintain effective working relationships with key stakeholders across all functions by becoming a key interface with, and advocate for, all groups.


• Sets a quality, continuous improvement, and risk based mindset and culture of problem solving through root cause analysis, Lean principles, and Risk Management.


• Leads & continuously improves quality KPI’s such as reduced waste, CAPA effectiveness and Audit performance outcomes.

Corrective and Preventive Action

• Manages the effective execution of all aspects of the CAPA system (i.e. Deviation Reports, Corrective and Preventive Actions, and Effectiveness Checks) for adherence to organizational or departmental targets.


• Manages the Customer Complaint process complaint investigations to ensure root cause, corrective actions, containment activities and risks have been appropriately documented.


• Partners with Regulatory affairs to ensure customer complaint adverse events are identified, investigated and reported in accordance with applicable international and federal guidelines.

Maintenance of the Quality Management System

·        Responsible for the management review process through development and generation of quality system metrics and trending and escalate issues to the Director of Regulatory & Quality or designate as required.

·        Manages the Internal Audit and Supplier Audit programs.

·        Actively leads, in tangent with the Person Responsible for Regulatory Compliance, customer and regulatory audits.

·        Manages the electronic Quality Management system.

·        Manages the Document Control System and Unique Device Identification processes.

Job Essentials:

·        Working knowledge of 21CFR Part 820, 803, 801, EN ISO 13485:2016 and MDSAP.

·        Working knowledge of nonconforming investigations and root cause analysis tools.

·        Interpersonal skills to effectively interact across functions working in a highly motivated team atmosphere

·        Strong written and verbal communication skills and proven ability to present to internal and external stakeholders

·        Strong analytical skills and comfort with learning new technologies, systems, and applications.

·        Strong and proven problem-solving skills

·        Ability to travel to work with customers and suppliers

·        Computer proficiency in Microsoft Office products (Excel, Outlook, PowerPoint, Word, Teams)

Qualifications

·        Minimum of 5 years Quality Management experience in the Medical Device Industry Experience as a lead auditor (Internal, 2nd party or 3rd party).

·        Experience interacting with the FDA, ISO registrars and other regulatory bodies.

REQUIRED EDUCATION, COMPETENCE, TRAINING AND KNOWLEDGE

·        Bachelor Degree in Engineering, Life Science, Business or related field of study or equivalent experience

·        Competency in Medical Device Quality Systems for a global company including but not limited to CAPA controls, purchasing, document control, customer complaints and label controls.

·        ASQ CQA, CQE and or RAPS Certification a Plus

Salary range $90,000 - $115,000 annually

Additional Information

All your information will be kept confidential according to EEO guidelines.