Supplier Quality Engineer II

About the role

Supporting Instrument, Cassette and Reagent Manufacturing, in addition to interfacing with Sourcing to develop and maintain the supplier quality improvement program. Functioning as the Manufacturing interface with Engineering, Sourcing and Quality Assurance for supplier sourcing and supplier performance and participates or leads in Quality Control processes associated with setting appropriate raw material specification, test method development, product development, product sustaining engineering, automated inspection methods (CMM experience preferred), equipment and method validations, document development, and document and engineering change control.

Responsibilities

• Maintain supplier quality metrics as required.
• Develop and optimize supplier performance using quality engineering principles and problem-solving skills.
• Achieve supplier selection & qualification for new products and sourcing activities.
• Assess supplier production control and quality programs, identify shortfalls to expectations.
• Coordinate supplier conference meetings, site visits and audits.
• Communicate quality issues, discuss root cause and drive corrective actions with suppliers.
• Drive continuous improvement projects with suppliers.
• Establish and fulfill annual CAPP objectives.
• Conduct or participate in applicable departmental and interdepartmental training.
• Monitor procedural and engineering change releases; assess departmental impact.
• Control departmental document change control, manufacturer change control and engineering change control activities.
• Develop specifications for raw materials, products, acceptance, etc.
• Participate in product planning and product realization processes.
• Participate in the Material Review Board.
• Participate or chair the Supplier Review Board.
• Lead or assist in supplier audits and audit reporting.
• Drive the resolution of department audit findings, observations, and recommendations.
• Lead or assist in the investigation and resolution of problems initiated through non-conformances, corrective action, or customer complaints.
• Other duties as assigned.

Requirements

• Bachelor's Degree in a technical field
• 7+ Years related experience and/or training (in lieu of degree)
• 4+ Years of quality, supplier quality, or manufacturing experience in a relevant industry.

Qualifications

• Advanced degree in a technical field and 2 years relevant work experience/training
• Proficient in Microsoft Word, Excel, Access and PowerPoint programs
• Effective oral and written communication skills across all levels (peers, managers, executives)
• Strong statistical and data analysis skills and problem solving techniques; SPC, DOE
• Thorough knowledge of FDA regulations and cGMP guidelines
• Highly organized with proven time management and prioritization skills
• Ability to work independently and with minimal supervision
• Ability to handle the pressure of meeting tight deadlines
• Fluent in using Microsoft Office suite

Skills

• ASQ Certified Quality Engineer preferred

Benefits

The hiring range for this position is $69,000-$117,000 annually. The salary range for this role represents the numerous factors considered in the hiring decisions including, but not limited to, educations, skills, work experience, certifications, etc. Beyond base salary, Diasorin offers a competitive rewards package focused on your overall well-being. We are proud to offer a comprehensive plan of health benefits, retirement and financial wellbeing, time off programs, wellbeing support and perks. Benefits may vary by role, country, region, union status, and other employment status factors. You may also be eligible to participate in an annual incentive program. An incentive award, if any, depends on various factors, including, individual and organizational performance.

Pay

$69,000 - $117,000 annually

Schedule

Not specified