Quality Manager Jobs

Come join a growing, steady company! Excellent Benefits and a great team to work with.

• Tuition Reimbursement
• Growth Opportunities
• Paid holidays
• Full Medical, Dental & Vision, 401(k), effective on your 1st day

Purpose: We produce medical devices that save and enhance lives!

Growth: Being a growth site we are looking for individuals that are looking for a chance to develop high-performing teams and to themselves develop advanced leadership skills.

Mission

We partner and innovate with our customers to provide the highest quality, life-enhancing medical devices in the world. This is a highly responsible, independent, and supervisory position responsible for all aspects of the quality improvement process. This position has 24 direct reports that support the general operations and new product introduction functions. This position requires strong medical manufacturing, customer relations, organizational, and leadership skills as well as a working knowledge of quality control measures and quality control programs in an ISO 13485 environment.

Responsibilities Include

• Adheres to Viant Core Values and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
• Organizes and leads regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
• Develops and maintains internal/external relationships with key customers, divisions, and departments in order to strengthen and maintain business operations and growth.
• Manage customer complaint and reject process to ensure accurate root cause analysis, timely response, and determination and implementation of corrective actions.
• Other projects and tasks as assigned.
• Provides training in the area of root cause tools, statistics, and quality systems.
• Coach, mentor, develop, direct, train and evaluate the work of the quality improvement personnel.
• Monitor site quality metrics and develop counter measures as needed.

Skills/Competencies:

• Detail-oriented with strong organizational skills
• Proficiency in Risk Management (ISO 14975)
• Practical application experience in continuous improvement methodologies to improve processes, strengthen the quality and drive efficiency.
• Ability to work cross-functionally and as part of a project team
• Work with diverse teams, guide teams through decision-making, facilitate agreement, build collaborative relationships, and focus on customer needs.
• Experience and demonstrated advanced proficiency in Process Validation (IQ, OQ, PQ, TMV)
• Advance proficiency in statistical tools (i.e. Gage R&R, Capability Analysis, Anova, etc.)
• Self-Motivated and strong ability to adapt to change
• Ability to think strategically with the capability to advise the resolution of technical problems using innovative ways.
• Experience with environmental monitoring practices and testing (ex. Endotoxin, LAL, etc.) is a plus
• Ability to read and interpret drawings
• Highly skilled in Quality tools e.g. FMEA, Risk Analysis, and Root Cause Analysis. Ability to read and write in English.
• Experience leading conversations with customers and auditors.

Requirements

Minimum Education:

• BS in Engineering or applicable technical fields. Master’s degree is a plus.

Minimum Experience

• 3+ years of leading successful teams or 3+ years of supervisory experience in similar fields.

Knowledge & Skills

• Six Sigma Black Belt Preferred.
• Proficiency in the application of ISO 13485 and ISO 9001 standards.
• Knowledge of the Injection molding process.
• Internal Auditor Certified preferred.

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.

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