Senior Quality Assurance Engineer

Responsibilities

Includes the following:

• Support the application of quality engineering/compliance of various functions and levels with technical responsibility or strategic input.
• Work with other engineering functions for product design, development, verification, and validation.
• Resolve quality-related issues in a timely and effective manner.
• Identify and provide direction for statistical support in both design and routine manufacturing activities for achieving required levels of product reliability.
• Develop and conduct training when needed.
• Lead complaint investigations. Document findings, and provide reports and analysis
• Lead in the completion and maintenance of risk management processes, such as the failure modes and effects analysis, hazard analysis, and other risk management tools/techniques.
• Additional responsibilities, as required.
• Identify and implement effective process controls to meet or exceed internal and external requirements, including the development of inspections and test methods.
• Ensure compliance with all federal, state, local, and company regulations, policies, and procedures
• Lead the investigation, resolution, and prevention of product and process non-conformances.
• Build supplier relationships by working collaboratively with component and service suppliers. Monitor supplier performance, conduct non-conformance investigation, product testing, and perform occasional onsite audits/visits (occasional travel may be required).

Skills/Requirements

Education and Experience:

• B.S. or M.S. degree in engineering or a scientific discipline is required.
• 10+ years of quality experience in the medical device industry following FDA regulations and ISO 13485 requirements; 3 years of decision-making responsibility.
• CQE certification preferred

Abilities/Skills:

• Ability to multitask and complete deliverables on time.
• Ability to work in an office environment, CER, and travel to supplier sites, as required.
• Strong technical writing and communication skills.
• Independent, team player, that leads by example.
• Ability to lead, represent, or participate during quality system audits.

Salary Range: $85K to $150K