Quality Engineer III

Location: Boulder, Colorado
Posted On: 3/8/2017
Job Code: Quality Engineer_CO
Job Description
The NPD Senior Design Quality Engineer is responsible for assisting new product development teams in meeting quality, time-to-market, and technology objectives through the development and qualification of manufacturing line process. This role assists new product development teams in providing guidance on process validation that consistently meet or exceed process quality requirements in a fast paced new product development environment. This person will also be responsible for transferring the line process responsibilities to sustaining resources upon Commercialization Exit. Success requires detailed knowledge of manufacturing methodologies, design control systems, process validation and verification practices, and quality management systems.

• Improves process quality performance for assigned product lines
• Oversees process validation and verification according to FDA requirements
• Identifies and manages process improvement initiatives through the evaluation and use of the following:
o Process flow mapping
o Process FMEA (Failure Mode and Effects Analysis)
o Control planning
o DOE (Design of Experiments)
o MSA (Measurement Systems Analysis)
o Process capability analysis
o Statistical analysis
o Quality inspection procedures, including sampling plans for finished devices
• Ensures that all tasks are conducted in accordance with Quality System procedures and identifies/implements best practices
• Organize, perform, and report manufacturing line and documentation audits for new products to ensure process quality
• Guide engineers and technical support staff on engineering test and build requirements
• Is a liaison between New product Development teams, Manufacturing, and Sustaining teams
• Develops positive relationships with New Product Development teams, Operations, and Sustaining to drive quality by design minimizing inspections, defects, and assembly issues
• Develops and implements innovative solutions to shorten TTM (Time To Market) and improve process quality in conjunction with NPD objectives
• Assures Corrective Action and Preventive Action plans are developed and executed at assigned process in compliance with the CAPA process
• Stays informed about advancement in area of expertise and is knowledgeable about new rules, regulations, and standards
• Is hands-on with the ability to provide insight and direction toward resolving quality and technical issues
• Execute tactical implementation of strategic plans
• Oversees the Device Master Record in the Change Order System
• Assists in designing and improving quality systems, processes and metrics
• Assist with training cross-functional team members in quality disciplines
• Applies six-sigma, LEAN, and project management principles to advance NPD objectives
• Participates in developing QA/RA department strategic plans
• Contributes to engineering schedules and plans
• Collaborates and works effectively across functional areas (R&D, Engineering, Mfg., etc.)
• Prepares monthly progress reports, internal/external formal presentations, and written reports
• Demonstrates knowledge and understanding of Good Manufacturing Practices and all applicable standards
• Assures compliance with company Standard Operating Procedures and policies
• Participates in team decision making, and demonstrates team problem solving and communication skills
• Maintains a clean, safe, and orderly work area
• Stops the manufacture and/or distribution of medical devices should it be determined that the safety, quality, identity of the product or process has been compromised
• Follows all safety procedures and SOPs
• Other quality related functions as required

Education Required:
• Bachelor's degree in Mechanical or Electrical Engineering, or related field.

Education Preferred:
• Master's degree in Mechanical or Electrical Engineering, or related field.
• Green or Black belt Six Sigma Certification (DFSS or DMAIC)
• ASQ Certification CRE

Minimum Experience:
Five (5) years experience in design, manufacturing, or quality engineering position (medical device experience preferred)
Two years experience in quality/reliability engineering practice in a regulated environment (FDA 21 CFR, ISO 13485, ISO 9000, FAA, Automotive, etc.)

• Knowledge of New Product Development Processes
• Strong knowledge of manufacturing, process validation, and process verification
• Leadership of or participation in cross-functional teams
• Ability to work with engineering on requirements, process improvements, measurement system analysis, and capability studies
• Background in six-sigma, LEAN, DFX, and related quality management tools
• Knowledge of engineering practices, test protocols, and documentation
• Knowledge of organizational structure and inter-related functions in developing medical devices
• Familiar with ISO 9001, ISO 13485, and 820 requirements
• Knowledge of analytical tools and methods, including statistics (Minitab preferred), DOE, and the use of computer/software packages related to design, development, and manufacturing
• Ability to resolve complex problems requiring detailed analysis, calculation, or experimentation
• Broad commodity expertise and knowledge of industry practices in area of expertise
• Proven project management skills
• Good written and oral communication skills
• Strong interpersonal and team building skills
• Skills in personal computer spreadsheet, word processor, and engineering tools
• Ability to operate light machine tools and metrology instruments
• Ability to interpret displayed results on metrology instruments

• Works with engineering teams and individual contributors to enhance new products development processes.
• Works with RA/QA and Documentation functions to establish proper procedures.
• Supports resolution of production or process problems. Leads changes as necessary.
• Works effectively on cross-functional teams.
• Supports Engineering and Manufacturing with specifications and technical information for process development.

Category:Non-IT  code:new
Job Requirements
new products development

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Contact Details
Sagar Rathore
E-mail Address