Quality Engineer Jobs

Responsible for the overall Quality Policies/Procedures and Programs at HydroWorx. Works with internal Supply Chain and Suppliers to continuously improve performance through driving and facilitating problem solving, implementing process controls, promoting risk mitigation, and developing quality assurance plans.

Drives major Quality improvement projects with cross functional teams including but not limited to Manufacturing, Engineering, and Supply Chain as well as with Suppliers.

Responsibilities

• Assists in the planning and execution of verification and validation testing to ensure adequate test coverage for new products and sustaining design changes.
• Perform other duties as assigned.
• Participates and supports various development activities including design reviews and Product Safety Committee.
• Performs New Product Development (NPD) gate audits to ensure project deliverables adhere to governing processes.
• Serves as key member of product risk assessment teams.
• Ensures quality products are developed in accordance to governing regulations and processes
• Drives key quality requirements (e.g. Design for Test, Design for Reliability, etc.) in new product development.
• Serves as the Quality & Regulatory stakeholder for product development release team.
• Reviews quality data to identify high priority issues relating to safety, complaints and systemic customer satisfaction.
• Support root cause analysis activities for the investigation of product complaints.
• Reviews and approves product design documentation.
• Actively participates and/or leads Design History File audits and follow-on remediation efforts as required.
• Actively participate and assist teams with Risk Analysis to include Risk Assessments, DFMEA/PFMEA’s, etc.
• Responsible for managing all tool and process validations – reviews and approves all validation documentation.

Qualifications

• 3+ years’ experience in quality engineering / quality assurance role under the Quality System Regulation, medical device or other FDA regulated industry required
• BS Degree-in Engineering or other technical degree

Skills/Competencies

• Excellent analytical decision making and problem-solving skills
• Experience with requirements management tools and systems engineering concepts desired
• Strong analytical skills
• CQA, CQE, CSQE, or RAC certification desired
• Strong presentation and communication skills
• Demonstrated ability to work and perform in team environments
• Strong collaboration with other departments
• Attention to detail
• Conflict resolution and negotiation skills
• Proficient in Microsoft Office
• Experience in New Product Development/ Medical Device Design required
• Ability to implement correction action programs
• Knowledge of ISO Quality System Standards desired

Physical Demands

The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, copy and fax machines, filing cabinets.

Tools & Equipment

Computer, telephone, copy & fax machines and company provided tools.

Work Hours

Monday through Friday, 8:00 a.m. to 5 p.m. Occasional evening and weekend work may be required as job duties demand.

Travel

As required by the position, generally less than 10%.

Training

Training for this position will be conducted per HydroWorx Training Program.

NOTE: This document is an outline of the primary tasks assigned and may be changed at the discretion of management, formally or informally, either verbally or in writing. Employees are expected to assist HydroWorx in achieving its goals even if such tasks are beyond the scope of this outline. The job description does not constitute an employment contract, implied or otherwise, other than an “at will” relationship and is subject to change by the employer as the needs of the employer and requirements of the job change.

This organization participates with E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.