Quality Engineer

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 Mediatech 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.

• Serves a resource for performing internal audits to ensure quality system compliance.

• Some travel is required as part of the job responsibilities.

Required Education/ Experience:

• Bachelor’s Degree – Engineering, Quality, Life Sciences or related field.

• Minimum of 3 years of experience in a Manufacturing environment or within a Quality function

Required Skills:

• Knowledge/experience in a regulated industry (cGMP, GLP, ISO, etc.)

• Proficiency with Microsoft Office products (Word, PowerPoint, Excel, Visio).

• Experienced with investigations using tools like (5Y, 8D, etc.)

• Demonstrated technical writing skills.

• Working knowledge of databases and spreadsheet applications to perform necessary tasks for preparing required data analysis, reports, documents and general communication.

• Able to use a systematic approach to drive to root cause understanding of problems to assure validity of corrective actions

Desired Experience / Qualifications / Skills:

• Advanced degree – Life Sciences or related field.

• Prefer exposure to ISO13485 and 21CFR820.

• Experience preforming CAPA, SCARS and risk assessments.

• Advanced proficiency with Microsoft Office products (especially in Visio and Excel).

• Familiarity/experience with Six-sigma/Lean.

• Understanding of typical (bio)pharmaceutical industry manufacturing strategies/processes/equipment.

• Proficiency with Minitab software.

• ASQ certifications preferred.

• Exposure to aseptic processing concepts.

• Uses rigorous processes and data to solve problems

• Can apply academic and experiential technical knowledge to solve problems

Soft Skills:

• Must be detail oriented.

• Able to work well both independently and in a group setting.

• Ability to work independently with strong time management and prioritization skills to handle multiple assignments and interact with project teams.

• Ability to make decisions regarding product disposition and corrective and preventive action effectiveness.

• Comfortable in giving direction to accomplish deliverables