Are you passionate about using cutting-edge technology to improve lives? As a Quality Design Engineer at Gilero, you'll play a crucial role in ensuring the quality of medical devices and combination products that make a difference in the lives and health of patients. You will be responsible for quality oversight of the design, development, and production of medical devices and combination products with a focus on systematic continuous improvement in the areas of risk mitigation, phase-appropriate design reviews, and qualification strategy implementation.

Join us in a collaborative and innovative environment where your contributions will make a real difference. You'll work with multiple disciplines and clients across a variety of products to help shape the future of healthcare technology, ensuring products meet the highest standards and positively impact patient outcomes across the globe.

Responsibilities:

• Represent the quality function in product development projects providing direction for development and commercialization activities.
• Author Design History File documents during the development process.
• Translate user input into measurable product requirements and specifications.
• Support design verification and validation activities, including authoring test protocols and reports.
• Manage, trend, and continuously improve assigned quality system elements (CAPA, Complaints, Supplier Management, External Audits, etc.).
• Participate in risk analysis assessments of medical devices.
• Maintain accurate and complete Design History Files, including regulatory submission documents.
• Facilitate manufacturing transfer, including preparation and execution of process validation (IQ/OQ/PQ) protocols, and development of production inspection plans.
• Investigate, disposition, and resolve nonconforming material events during product development, pre-production, and production phases.
• Author new or revised procedures, train team members, and release quality system procedures, as required.
• Support internal and external audits.
• Support supplier selection, qualification, and ongoing monitoring.
• Facilitate investigations to determine root cause and failure modes.
• Maintain quality records, summarize data, and report quality metrics to the organization.
• Execute quality event initiation, investigation, and closure for nonconformances, CAPA, change control, and complaints. Perform effectiveness checks.

Skills/Qualifications:

Minimum:

• Able to work in the office at least 3 days a week
• Bachelor's degree in engineering, science, or relevant field
• 2+ years in a regulated manufacturing and/or development environment
• Proficiency with FDA 820 CFRs/ISO 13485/cGMP quality management system and requirements for medical devices and/or combination product development and manufacturing
• Experience with electromechanical medical devices and IEC 60601
• Strong preference for experience in pharma or medical device manufacturing and/or development environment
• Experience using risk analysis and continuous improvement concepts
• Experience with GxP requirements
• Experience supporting audits
• Strong technical written and verbal communication skills
• Excellent interpersonal, change management, planning, and organizational skills
• Excellent oral, written, and presentation communication skills

Preferred:

• Master's or advanced degree in a relevant field
• GxP terminology, experience, and working knowledge in phase-appropriate environments ranging from pre-clinical to commercial
• Project management experience
• CQE, ASQ, or related certification

Personal Attributes:

• Meets Gilero Core Values: Collaboration, Integrity, Innovation, Excellence
• Comfortable and productive in a fast-paced, entrepreneurial environment
• Commitment to excellence and quality service to external and internal customers
• Commitment to established policies and procedures, while contributing to continuous improvements

Eligibility To Work

Candidates must be legally eligible to work in the US without requiring current or future sponsorship. Gilero does not offer sponsorship for employment authorizations (work visas).

We are an E-Verify employer and confirm work authorization for all new hires.

Why work at Gilero?

Founded in 2002, Gilero, a Sanner Group company, is an international contract engineering firm that specializes in the design, development, and manufacturing of novel medical devices and drug delivery products. At Gilero, we are proud of the culture we have built that directly reflects our values of excellence, integrity, innovation, and collaboration. Motivated by our purpose to benefit people and improve patient outcomes, our team continues to grow at a rapid pace. US locations include Carlsbad, CA; Chicago, IL; as well as NC locations in Raleigh, Durham, Greensboro, and Pittsboro.

You will enjoy an annual bonus plan, Medical (3 BCBS plans to choose from), Guardian dental and vision, company-provided life insurance, short-term and long-term disability, 401(k) with a match the first month you start with a zero-vesting period, and access to LinkedIn learning for personal and professional development.