Role Purpose

• Develops, modifies, applies and maintains quality evaluation systems and procedures for processing materials into finished product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment. Areas of specialization include design, validation, root cause analysis, statistical risk management, production control or product evaluation and reliability as they apply to product or process quality. May be certified in lean and six-sigma quality engineering methodologies. May also be responsible for PEx project portfolio assuring the effective use of different improvement methodologies (DMAIC, Lean, DESGN, etc.) toward the achievement of plant strategic goals. Exercises judgment within defined procedures and practices to determine appropriate action.

Key Responsibilities

• Lead and participate in project teams to quickly and effectively implement improvement initiatives or manufacturing process improvements.
• Provide manufacturing support activities to include validation projects, equipment validation projects, and or involvement in improvement projects related to products or services consistent with FDA requirements for medical device products.
• Participate in continuous improvement and Performance Excellence activities to include leading, participating, or coaching project teams, facilitating events, or providing training.
• Provide technical support and guidance to other staff and/or project team members in Quality Systems improvement efforts.
• Apply quality engineering practices and guidance to support project teams and manufacturing operations using Six Sigma tools, FMEA, CE Diagram, CE Matrix, DOE, MSA, Validation Protocol development, review, approval and Control Plans.
• May lead execution of validation protocols.
• Develop/Revise Quality Plans including incoming, in-process and final inspection, and provide training to those affected by the plans.
• Perform technical reviews and interprets data for accuracy of equipment/process performance.
• Write Technical Reports and Protocols, as needed, and write, revise, and review SOPs.
• Frequently interacts with colleagues, team members, supervisors, and other teams/departments.
• Oversees the change management program to assure there is a proper technical review of requested changes and that there is a risk assessment of requested changes.
• Manages CAPAs assigned to the QE department to closure and assures corrective actions are effective.
• Participates in MRB, reviews and/or completes nonconformance reports, FIRs, and CAPA documents to assure root cause analysis is reached and corrections are appropriate to prevent further nonconformances.
• Reviews QS metrics and makes recommendations for corrective actions.

Required Skills:

• Minimum of a 4-year degree in relevant fields of study such as microbiology, chemistry, biology, or engineering with 4-7 years of work experience
• Can balance team and individual responsibilities
• Can apply basic mathematical concepts such as percentages, ratios, and proportions to practical situations
• Basic computer knowledge in Microsoft Word and Excel
• Must be detail oriented
• Able to work well both independently and in a group setting
• Demonstrated technical writing skills

Desired Skills:

• Advanced degree
• Familiarity with cGMP, ISO 9001, ISO 13485, QSR 21 CFR 820,210,211 is highly desirable
• Capable of Certified Quality Engineer recognition by ASQ
• Track record of delivering results
• Six-Sigma I Lean experience
• Proficiency in Minitab, MS Project