Design Quality Engineer Jobs

**THIS IS A LOCAL REMOTE POSITION AND YOU MUST LIVE WITHIN 50 MILES OF JACKSONVILLE, FL**

Job Summary

Works with cross-functional teams to ensure the highest level of quality is being applied and achieved throughout the entirety of the KLS design process. Reviews and evaluates thoroughness and accuracy of all design process deliverables. Assists in the post-market evaluation of product and actively participates in all aspects of investigations and corrective actions. Performs job requirements as a local (Jacksonville, FL) remote employee with the capability of working onsite as needed.

Essential Functions, Duties, and Responsibilities

• Identify quality assurance process bottlenecks and suggest actions for improvement
• Implement strategy to meet company and project Quality Objectives
• Audit and qualify suppliers as needed by Purchasing
• Review product data and identify deficiencies
• Coordinate with Suppliers to create Quality Agreements
• Participate in design reviews
• Adjust the QMS processes as regulations change or improvements are needed
• Prepare and provide metrics to Senior Management on effectiveness of the QMS system
• Assist in risk management, analysis, and action when field actions occur
• Support internal and external audits
• Mentor team members on application of QMS procedures by participating in cross functional product development and life cycle management activities
• Identify key KPIs for product quality
• Prepare and present reports and metrics to Senior Management
• Assist or conduct complaint investigations as directed by Management
• Oversee continuous improvement projects
• Assure risk management activities are performed per process in accordance with Design Control Requirements per ISO 14971
• Collect quality data including complaints and assure data is integrated into future design activities
• Assure project deliverables comply to QMS procedures and Regulatory Requirements
• Assure design and development activities are performed per process in accordance with Design Control Requirements per 21CFR820
• Coordinate root cause investigations and plans of actions for CAPA activity
• Quality planning and monitoring to assure project and process performance meet established criteria

The above cited duties and responsibilities describe the general nature and level of work performed by people assigned to the job. They are not intended to be an exhaustive list of all the duties and responsibilities that an incumbent may be expected or asked to perform.

Educational and Experience Requirements

• Experience in Risk Management Planning, UFMEAs, DFMEAs, EV, DV, MSAs and ideally PFMEAs, Process Verification & Validation, and Supplier Quality
• 8+ years of experience in medical device industry specific to job role
• Intermediate abilities with both MS Excel and MS Word
• 4-year degree or higher in Engineering, or a related scientific discipline,
• And preferred 4 years work experience in similar job description as a design quality engineer, or

Knowledge, Skills, and Abilities

• Adhere and support KLS Martins quality and safety policies and procedures.
• Experience in Risk Management Planning, UFMEAs, DFMEAs, EV, DV, MSAs and ideally PFMEAs, Process Verification & Validation, and Supplier Quality
• Must be able to work independently and as a member of a cross-functional team, to multi-task and do what it takes to meet high expectations and tight deadlines. Will be working on highly visible projects in high-pressure situations
• High level of customer service displaying positive attitude.
• Must be able to delegate tasks as lead when there are multiple design assurance members on a program
• Must have good written & oral communication skills and the ability to communicate appropriately with different engineering teams, Project Management, vendors, partners, and customers

Skill Requirements

• Retrieve and compile information
• Written communication
• Verbal communication
• Investigate, evaluate, recommend action
• Organize and prioritize information/tasks
• Maintain records/logs
• Public speaking/group presentations
• Typing/computer keyboard
• Utilize computer software (specified above)
• Abstract mathematical concepts (interpolation, inference, frequency, reliability, formulas, equations, statistics)
• Verify data and information
• Research, analyze and interpret information

Physical Requirements

• Hear/Listen
• Sitting for extended periods
• Standing for extended periods
• Writing
• Walking
• Speaking
• Maintain regular, punctual attendance
• Extended periods viewing computer screen
• Reading

Hazards

• Normal office environment

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.