Senior Quality Engineer - RxFunction

We are seeking a highly skilled and experienced Senior Quality Engineer to join our team. As a Senior Quality Engineer, you will be responsible for establishing and implementing the methods required to meet technical quality standards across the company. This will require frequent interaction with cross-functional teams and personnel, especially peers in Operations and Engineering, to develop and manufacture marketed medical devices and to support project and objective completion.

Duties:

• Identify and implement appropriate technical quality standards, methods and acceptance levels

• Oversee the quality inspection / test program, including the selection of suitable equipment and sampling plans, the development of methods and procedures, and the training of personnel

• Lead the Material Review Board (MRB) and ensure the proper disposition of nonconforming products and the timely processing of documentation

• Work directly with suppliers to resolve quality issues

• Represent the Quality function on product development projects and complete assigned tasks and deliverables per schedule

• Conduct and document failure investigations for products and processes, including in support of customer complaints, nonconforming events, and CAPA

• Work with other engineering functions to: identify and estimate product and process risks, plan and implement needed controls, and monitor and measure critical performance indicators

• Provide technical quality inputs into product and process validations to ensure that outputs consistently meet specified requirements and quality standards

• Make recommendations for product and process improvements

• Support third-party, supplier and internal quality audits as a technical expert

• Other duties as assigned

Qualifications:

• Four-year technical degree (engineering, mathematics, statistics)

• Seven years’ experience in a quality assurance role(s); medical device experience preferred

• Solid knowledge of relevant FDA regulations and quality management system standards, including 21 CFR 820 and ISO 13485

• Ability to read and accurately interpret dimensional requirements on drawings and specifications

• Advanced knowledge of root cause analysis and continuous improvement methods

• Ability to apply valid statistical models and techniques (T-test, F-test, ANOVA)

• Demonstrated proficiency in process validation design and analysis of results, including IQ-OQ-PQ and Gage R&R studies

• Identify, estimate and control product and process risks using suitable methods

• Desire and ability to train and mentor other technical staff

• Excellent communication skills, both verbal and written

• Advanced computer skills, e.g., MS Office®, Minitab® or other statistical software

We offer competitive compensation packages, including benefits and opportunities for professional development and growth. If you are a highly motivated and detail-oriented individual with a passion for quality, we would love to hear from you.