Description

We are hiring a Quality Engineer II.

The Quality Engineer role is the quality and technical liaison between engineering, internal and supplier manufacturing operations in support of the product life cycle. The Quality Engineer is accountable for supporting design transfer, design / process validation and helping to establish/track quality metrics.

Essential Responsibilities:

• Quality Engineer II supports and defines the quality requirements to design and manufacturing engineering teams, including customer and/or supplier expectations, regulatory requirements, applicable voluntary standards and corporate requirements relative to product safety and efficacy.
• Review, assess and approve product design milestones, Design History Files and deliverables to ensure compliance throughout product development cycle.
• Provide support to CAPA Teams during containment, root cause investigation, plan development, and verification of effectiveness activities.
• Provides guidance about Six Sigma principles and risk management activities (Sampling, Acceptance Criteria, DOE, Statistical Process Control, Root Cause Analysis, FMEA, control charts, capability analysis)
• Perform analysis of reports and Statistical Process Control (SPC) data to identify trends and necessary corrective and preventive actions.
• Lead part qualification and supplier qualification activities
• Supports and provides guidance to Manufacturing Engineering during the process development, design transfer, and validation activities.
• Develops and implement standard methods for inspection, testing, and gage R&R, including the evaluation of validation requirements for TIDI manufacturing and/or suppliers and collect and analyze quality metrics relating to company/supplier quality.
• Troubleshoot and direct the resolution of quality issues by fostering effective interdepartmental and cross-functional partnerships.
• Provides guidance and coaches others on use of principles such as Sampling, Acceptance Criteria, DOE, Statistical Process Control, Root Cause Analysis, FMEA, control charts, capability analysis etc.

CORE VALUES & GUIDING PRINCIPLES:

• Understands internal and external customers
• Assure a safe work environment
• Encourage individual development Demonstrates teamwork and flexibility/adaptability
• Demonstrates honesty
• Keep our commitments
• Think systemically and ensure constancy of purpose
• Lead with humility and respect every individual
• Focus on process, embrace scientific thinking, flow and pull value, assure quality at the source and seek perfection

Qualifications:

• Bachelor's degree in an Engineering discipline or a related subject
• 5+ years' relevant experience in a regulated manufacturing environment, preferably within the medical device industry.
• Process Validation experience highly preferred.
• CQE certification highly preferred.
• Working knowledge of FDA requirements associated with medical device design and manufacturing.
• Working knowledge of industrial quality engineering, six sigma techniques, and statistical analysis.
• Ability to establish cause and effect relationships, solve problems, apply scientific methods and optimize processes.
• Ability to problem solve and develop appropriate corrections and improvements.
• Must be able to communicate effectively, in writing and verbally, with people of various educational & technical backgrounds.
• Ability to achieve credentialing through Vendormate and other Vendor Credentialing

Estimated starting annual base salary pay ranges is $90,000 - $110,000, less applicable withholdings and deductions, paid on a bi-weekly basis. Please note that the actual compensation offered may vary based on relevant factors as determined by the Company, which may include, but is not limited to, location, experience, qualifications, education, skillset, and market conditions. The target base compensation for this role is in the low to middle of the range, with the top of the range reserved for only exceptional circumstances. TIDI Products offers a competitive benefits package to eligible full-time employees, which currently includes medical, dental, and vision plans, 401(k) with employer matching contributions, life insurance, paid time off, tuition reimbursement, and more, as well as paid sick leave in accordance with applicable law. Each benefit is subject to eligibility requirements as specified in plan documents, and the Company reserves the right to modify the benefits it offers from time to time.