2405 - 25548 - Quality Engineer

DeRoyal is an Equal Opportunity/Affirmative Action employer. Interviewing and hiring practices at DeRoyal do not discriminate on the basis of race, color, sex, sexual orientation, gender identity, age, national origin, physical or mental disability, genetic information, veteran status or any other category protected by law.

2405 - 25548 - Quality Engineer

Global medical device manufacturer, DeRoyal, is actively searching for an experienced Quality Engineer to join our corporate Research and Development team!  The Quality Engineer will strive to improve the way care is delivered through driving quality during the research and development and post-market surveillance process.

Some key responsibilities of this role include:

• Performs technical duties required to update records (specifications, testing, etc.) for DeRoyal legacy products to the most current regulations and standards.
• Provides engineering/technical support to international registrations (such as MDR/CE marking).
• Performs complaint investigations that require engineering/technical support.
• Designs experiments to understand sources of variation in either the design process or the production process.
• Maintains the technical documentation (design history file and device master record) for DeRoyal products post development.
• Supports technical activities required for process validations such as installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
• Supports technical activities required to verify package integrity and production functionality post aging (accelerated and real time)
• Improves research and development standard operating procedures (SOPs), forms, and templates to improve efficiency and compliance.
• Performs gap analysis for technical standards and manages action items required to resolve any gaps identified.
• Manages corrective and preventative actions and non-conformities.
• Leads updates to risk management files per ISO 14971
• Reviews and approves engineering change orders (ECOs)
• Provides technical support to manufacturing, quality, marketing, customer service, and management as needed.

Basic Qualifications:

• B.S. in Engineering, Science, Math, or another related technical field.
• 5+ years’ engineering experience working in the medical device or pharmaceutical industry.
• Extensive knowledge of various regulations/standards (E.g., 21 CFR 820, ISO13485, ISO14971, MDD/MDR).

Preferred Skills:

• Detail oriented
• Organized
• Strong leadership skills
• Problem solving
• Effective communicator (verbal and written)

• Self-starter with ability to manage multiple projects with limited oversight

• Collaborative; can easily get along with others
• Open minded to new ideas

Preferred Qualifications:

• Direct experience as a quality engineer for a medical device company
• Experience leading projects
• Experience working with a mechanical test frame
• Experience working with CAD software such as SolidWorks
• Experience with statistical analysis
• Experience working with usability standards (IEC 62366)
• Experience working with software development standards (IEC 62304)
• Experience working with installation qualification (IQ), operational qualification (OQ) performance qualification (PQ)