Design Quality Engineer

The Design Quality Engineer is a key member of the QARA team, responsible to manage QA functional aspects of New Product Development, Design History File (DHF) maintenance, and product change controls, ensuring compliance with applicable standards and regulations.

The DQE will partner with the Engineering teams, QMS Manager, Product Quality, and staff responsible for maintaining the electronic QMS software (MasterControl) to effectively implement continuous improvements, monitor key quality performance indicators, and meet established goals. This manager will also provide mentoring, leadership, and development of any direct reports.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ensure product/process compliance with the requirements of applicable standards and regulations including ISO 13485, ISO 9001, FDA QSR, MDD/MDR, PED/TPED, MDSAP, and country-specific requirements.
• Ensure product development proceeds in accordance with established procedures and in conformity with applicable standards and regulations.
• Ensure product design controls are maintained and enforced, and that product DHFs are properly maintained.
• Ensure awareness of applicable harmonized standards and adherence to established SOPs and document control practices.
• Support the QMS functions including CAPAs, change controls, and Post-Market Surveillance, as well as Internal audits, Vigilance, Document Control, and Continuous Improvements.
• Support Product Quality colleagues on new product releases and changes to existing products, including labeling and design transfer activities.
• Support verification and validation efforts associated with new product development and sustaining engineering effort and/or product changes.
• Develop and maintain product risk management files based on regulatory (e.g. ISO 14971, MDR, TPED, and PED, etc.) and post-market requirements.
• Establish, monitor and report on quality metrics, reviewed in monthly Quality Review meetings
• Support annual Management Review meetings and 3rd party external audits.
• Ensure compliance to training programs in the business unit and satellite facilities to ensure personnel are familiar with and knowledgeable regarding product development, harmonized standards, change control, and risk management processes and requirements.

Competencies/Success Factors

• Detail Orientation / Quality Focus
• Organizing Skills
• Results Focus / Output Orientation
• Adaptability / Flexibility
• Negotiation Skills
• Team Orientation
• Coaching / Developing Others
• Change Management

Supervisory Responsibility

This position may supervise Quality Assurance support staff.

Work Environment

This job operates in a professional office environment and manufacturing/distribution environment. The role may be remote or in-person at the corporate headquarters and / or manufacturing facility.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. This is largely a sedentary role; however, some activity is required. This would require the ability to lift, bend or stand as necessary.

Travel

This position requires up to 20% travel. Some of the travel may be international.

Required Education and Experience

• Bachelor’s degree from a four-year college or university, preferably an engineering or technical degree
• 10 years of medical device experience required
• Experience with various Codes and Standards (ISO 13485, FDA QSR, MDR, MDSAP, etc.) required
• Experience and working knowledge with international QMS requirements
• Good communication skills at all levels (written and verbal)
• Proven ability to work with cross-functional teams and in a project management environment
• Demonstrated ability to plan and manage multiple tasks/projects

Preferred Education and Experience

• MBA or master’s degree.
• Related certifications commensurate with the role.
• Change management experience is preferred
• Verification and Validation experience is preferred

Additional Eligibility Qualifications

None required for this position.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

CAIRE is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any other class protected by federal, state, or local law.