**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

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

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.

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

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

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

• 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
• 8+ years of experience in medical device industry specific to job role
• Intermediate abilities with both MS Excel and MS Word
• Experience in Risk Management Planning, UFMEAs, DFMEAs, EV, DV, MSAs and ideally PFMEAs, Process Verification & Validation, and Supplier Quality

Knowledge, Skills, and Abilities

• Adhere and support KLS Martins quality and safety policies and procedures.
• 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
• Experience in Risk Management Planning, UFMEAs, DFMEAs, EV, DV, MSAs and ideally PFMEAs, Process Verification & Validation, and Supplier Quality
• 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
• High level of customer service displaying positive attitude.

Skill Requirements

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

Physical Requirements

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

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.