Quality Engineer Jobs

Welcome to an inspired career.

We are proud of what we do, and we continue to do more. That’s why we need you—to help us make a significant impact by tackling on increasingly complex challenges, leaping beyond the status quo and advancing our mission.

Join us as Quality Engineer-Contract and you’ll be part of a culture that welcomes diversity, thinks differently to solve problems, works collaboratively as one team, and delivers meaningful innovations that impact people’s lives.

How you will make an impact

As the Quality Engineer-Contract, you will lead quality engineering activities for commercial and development combination products. You will also participate in quality engineering activities for commercial scale up prior to product launch and support contract manufacturing.

In this role, you’ll have the opportunity to:

· Evaluate mechanical product design and identify potential design quality issues and drive technical decisions.

· Lead and support DHF and DMR content completion, integrity, and regulatory & standards compliance; collaboratively communicating and resolving gaps.

· Lead CAPA/NCR/SCAR/complaint investigations and reports

· Supports and ensures the establishment of objective and measurable product requirements.

· Support engineering print specification definitions, development, and changes

· Lead preparation and maintenance of risk management files from product conception through post market surveillance

· Develop and maintain product release testing plans, associated test methods and procedures.

· Support design test and inspection method development and validation

· Support design verification/validation and reliability study execution

· Support contract manufacturing activities including Process Development, Process Validation (IQ/OQ/PQ), and Nonconformance Resolution

· Identifies and leads continuous improvement projects and quality systems improvements.

To succeed in this role, you’ll need:

• BS degree in an engineering or physical/life science field with a minimum of 5 years relevant experience within the medical device industry or related function (a combination of education and experience may be considered)

• Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance
• Good statistical data analysis skills
• Background in manufacturing processes for drug-device combination products related to development and commercial programs.

· Excellent verbal and written communication skills

· Ability to collaborate with internal customers, 3rd-party partners, and CMOs.

In return, we offer you:

· Hybrid work flexibility

· A collaborative, innovative team that works as one to amplify your impact on your career, the work you do and patients’ lives.