Senior Quality Engineer, MedTech - Risk & Validation Lead

bdx; Tempe (AZ); On-site; USD 90,000 - 130,000; Full time

Job summary

BD is a leading medical technology company seeking a technical leader to support product leadership and risk management for new product development and sustaining activities for combination products. The role may include manufacturability, scalability, manufacturing transfer and post-launch sustainability across product lines.

The position requires BS in Engineering with 5+ years in engineering/quality engineering in medical devices or pharmaceuticals, and knowledge of ISO 13485, ISO 14971, and

Qualifications

• BS in Engineering.
• Minimum of five years’ experience in engineering or Quality engineering within the medical device, pharmaceutical, or equivalent industry.
• Pharmaceutical or combination product experience preferred.
• Knowledge of ISO 13485, ISO 14971, 21 CFR 210/211/820.

Responsibilities

• Technical leadership in medical device operations (manufacturing, process development, QA).
• Leads development of risk assessments and test methods.
• Leads component qualifications, design validation/verification and process validation.
• Leads product investigations.
• Ability to make and present risk-based decisions.
• Assess product changes against product design.
• Supports translation of design inputs into manufacturing control plans.
• Develop and implement procedures to comply with corporate and industry standards.
• Coordinates and/or directs all aspects of product development activity related to a product line.
• Quality engineering representation on Product Development Teams.
• Quality engineering representation on Design Review Teams.
• Prepare and present project updates and technical discussions.
• Participate in project planning, budgeting, scheduling, and tracking.
• Support internal and external supplier audits.
• Provide support to the regulatory department in writing technical submissions.
• Comply with company procedures and policies, government regulations.
• Ability to travel up to 25% of time.
• Other duties and projects, as assigned

Skills

Quality engineering

Risk assessment

Project leadership

Statistical analysis

Cross-functional teamwork

Education

BS in Engineering

Tools

Sampling plans

Root cause analysis

Statistics

Process validation

Design validation

Job description

BD is a leading medical technology company seeking a technical leader to support product leadership and risk management for new product development and sustaining activities for combination products. The role may include manufacturability, scalability, manufacturing transfer and post-launch sustainability across product lines.

The position requires BS in Engineering with 5+ years in engineering/quality engineering in medical devices or pharmaceuticals, and knowledge of ISO 13485, ISO 14971, and