Manufacturing Quality Assurance Engineer III

Job Summary

Provides complex quality engineering work for specific product lines under broad supervision and guidelines. Core duties include failure investigation, determination of disposition of nonconforming materials, risk analysis documentation and processes, quality inspection plan definition/refinement, data collection and trending, supplier quality issue resolution, validation/protocol data review, and optimization of quality systems and documentation.

• Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment to make minor adaptations and modifications.
• Investigates a moderate number of engineering variables to complete assignments with clear objectives.
• Works independently on standard projects, with assistance for unusual problems.
• Manages risk documentation for assigned product lines or processes; identifies and updates failure modes and related process/product improvements by facilitating teams and implementing required changes.
• Reviews, approves, and generates Engineering Change Notifications (ECNs) to update or create verification, validation, monitoring, and inspection methods, procedures, and test protocols specific to assigned product lines, processes, and production controls.
• Evaluates and participates in supplier selection by monitoring supplier performance, collecting and trending data, and performing supplier quality audits where required.
• Reviews nonconformance records (internal/external) to determine disposition, root cause, and necessary corrective and preventive actions.
• Ensures containment (identification, segregation, and reconciliation) of nonconforming product to prevent unintended use.
• Identifies and implements changes to maintain the continued suitability and effectiveness of the quality management system using quality policy, objectives, audit results, and data analysis.
• Evaluates the manufacturing environment to ensure adequate environmental control, monitoring, sufficient personnel, and safety production controls.
• May participate in design and development activities.
• Performs other related duties and tasks as required.

• Lifting – Not to exceed 50 lbs.
• Writing, sitting, standing, bending, fine motor skills, reading, vision, color perception, depth perception, field of vision/peripheral.
• Exposure to noise, chemical vapors.

• Bachelor's Degree in Chemistry or related field with five years of quality engineering experience.
• Strong interpersonal, organizational, and verbal and written communication skills; ability to work as an effective team member.
• Working knowledge of 21 CFR 820 (Quality Systems Medical Devices), ISO 13485, ISO 14791, and other medical device related standards.
• Proven ability to work effectively in a team environment through conflict resolution and negotiations.
• Working knowledge of statistical methodologies, quality control, and manufacturing tools such as applied statistics, lean manufacturing, and Six Sigma.
• Proficient computer skills, preferably with spreadsheets, word processing, database, and other applicable software programs.

• Medical device experience or equivalent experience in a regulated industry.
• Experience with SmartCAPA, Oracle, and Crystal Reports.
• Experience handling deviations, investigations, and CAPAs.
• Experience in medical devices.

• Engineering techniques, evaluation, selection, application.
• Engineering variable analysis.
• Plans, surveys, structures, equipment.
• Supervisory assistance.
• Special projects/ECN's/prototype creation.
• Nonconformance causes, corrective actions, dispositions.

• Multiple shifts and hours to choose from:
  Days, Swing, Nights.
• Medical, dental, and other insurances (eligible after 30 days).
• Low cost onsite medical clinic.
• Two onsite cafeterias.
• Employee garden and gardening classes.
• Three weeks vacation; one week sick time; paid holidays.
• 401(k) and health savings account.