Sr. Manager, Operations Quality Engineering

Description

The Sr. Manager, Operations Quality Engineering provides leadership and drives results in all aspects of the product lifecycle to ensure the highest level of quality in existing product lines and new technologies, and their compliance to applicable regulations and standards.

Responsibilities

• Manage the operations Quality Engineering (QE) function; responsible for maintaining high quality, compliance and customer performance for our existing products and future commercial products.

• Use professional concepts and company objectives to resolve complex issues in creative and effective ways.

• Lead the operations of the QE team including hiring, performance management, and talent development. Mentor and develop Quality Engineers to ensure their success.

• Define roles, responsibilities, and goals for the QE department.

• Work with Senior Leadership and cross-functionally to establish strategies, priorities, and goals for risk management, failure analysis, process validation, process reliability, trend analysis, statistical quality, and process control.

• Plan, schedule, delegate, and track QE projects accordingly in support of the company's goals and objectives to ensure initiatives are successfully implemented.

• Provide subject matter expertise with design of experiments, process validations, statistics, test method validations, measurement system analysis, sterilization validations, new product development, and risk.

• Develop mastery of company products and analyzes complaint data, post market surveillance and risk analysis to assist in the identification of potential product improvements based on sound engineering principles.

• Work with design quality engineering and advanced manufacturing engineering teams to transfer products and processes into the production environment with high quality and compliance; work with the sustaining manufacturing engineering team to support these products within the production environment.

• Review document changes for impact on specifications, product quality, and compliance.

• Transfer products and processes from one global production site to another.

• Lead in identifying risk, developing mitigation strategies, alternative solutions, resolving issues, etc. in collaboration with cross-functional groups.

• Continually improve technical processes and ensure reliability and implement inspections that meet the company's quality standards.

• Assist with improvements to the company's quality system.

• Participate in internal and external audits (e.g., FDA, ISO, etc.).

• Perform additional duties and special projects as assigned.

Qualifications

• Bachelor's degree in Engineering (Mechanical, Biomedical, or Materials preferred).

• Minimum of 8 years of relevant experience with medical devices, minimum 3 years of managerial experience in a quality engineering role or adjacent role (Manufacturing Engineering, R&D etc.) Previous experience hiring, developing, and building a strong team culture.

• Excellent, proven interpersonal, verbal, and written communication skills.

• Critical thinking skills and good judgment.

• Possess strong interpersonal skills; ability to forge strong relationships across teams and other departments.

• Strong ability to influence peers and executive leadership.

• Proven track record of working with applicable regulations and standards, e.g. QSR, ISO 13485.

• Ability to navigate a fast-paced dynamic environment where there is not a structured process to do everything. The individual will be looked upon to offer flexible processes and define future best practices for product development and sustaining commercial products.

• Good knowledge of Design Controls and Risk Management for medical devices.

• Proven track record of medical device commercialization, production line scaleup, solving product quality challenges, new plant transfers.

Inari Medical offers competitive health and wealth benefits for our employees. The base pay range for this position is $150,000 - $190,000. A range of factors, including location, skills, and experience, will be considered. Actual compensation may vary.

Inari Medical, Inc. advises applicants that employment is subject to completion of a successful background check.