Quality Engineer - (Biotech/Biomedical) at Nesco Resource
Manassas, VA
About the Job
Hours: M-F 8:00a.m.-5:00p.m. - 1 hour lunch break unpaid
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.
Performance Metrics
Quality
Culture
Cost
Customer Satisfaction (Product Quality) Continuous improvement
Training compliance cGMP compliance
o Reduce cost of quality through product and process improvements
Competencies
People:
Learning on the Fly
o Learns quickly when facing new problems
o Looks to others for input on approach and knowledge
o A relentless and versatile learner; open to change; is not intimidated by new experiences
o Analyzes both successes and failures for clues to improvement
o Enjoys the challenge of unfamiliar tasks
Approachability
o Is open and engaging
o Is aware of comfort level of others and works to put everyone at ease
o Welcomes and receives input from many sources
o Has established & maintains a strong network in the facility
Listening
o Actively listens to all input
o Does not let pre-conceived ideas hinder ability to hear other input
o Actively works to understand the position of others even when there is disagreement
o Acknowledges the input of others
Interpersonal Savvy
o Relates well to all kinds of people-up, down, and sideways, inside and outside the organization.
o Builds appropriate rapport.
o Builds constructive and effective relationships.
o Uses diplomacy and tact.
o Can diffuse even high-tension situations comfortably.
Patience
o Recognizes and is tolerant of differences in people
o Works to assure everyone is at the same point of understanding before moving forward
o Takes the time necessary to assure everyone fully understands their role in the project or activity
o Follows established processes and change control procedures when implementing change
Perseverance
o Pursues everything with energy, drive, and a need to finish throughout entire duration of a project or activity
o Seldom gives up before finishing, especially in the face of resistance or setbacks
Influencing
o Builds support for ideas
o Gains cooperation from others to obtain information and accomplish goals
o Actions are adapted to specific audiences
o Influences through others
Business:
Action Oriented
o Proactive about making things happen
o Identifies opportunities for improvement or change and moves forward
o Does not wait to be assigned tasks
o Enjoys taking on new challenges
Customer Focus
Leadership
Drive Deployment
o Communicates team goals with clarity and focus
o Provides expertise to achieve project goals
o Holds others accountable for results and continuous improvement
Pursue and Apply Learning
o Demonstrates a curiosity for trying new things
o Continuously develops own leadership capabilities
o Communicates and applies lessons learned.
o Coaches and mentors employees
Experiences/Education
Required:
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:
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
Nesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.
Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
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.
Performance Metrics
Quality
Culture
Cost
Customer Satisfaction (Product Quality) Continuous improvement
Training compliance cGMP compliance
o Reduce cost of quality through product and process improvements
Competencies
People:
Learning on the Fly
o Learns quickly when facing new problems
o Looks to others for input on approach and knowledge
o A relentless and versatile learner; open to change; is not intimidated by new experiences
o Analyzes both successes and failures for clues to improvement
o Enjoys the challenge of unfamiliar tasks
Approachability
o Is open and engaging
o Is aware of comfort level of others and works to put everyone at ease
o Welcomes and receives input from many sources
o Has established & maintains a strong network in the facility
Listening
o Actively listens to all input
o Does not let pre-conceived ideas hinder ability to hear other input
o Actively works to understand the position of others even when there is disagreement
o Acknowledges the input of others
Interpersonal Savvy
o Relates well to all kinds of people-up, down, and sideways, inside and outside the organization.
o Builds appropriate rapport.
o Builds constructive and effective relationships.
o Uses diplomacy and tact.
o Can diffuse even high-tension situations comfortably.
Patience
o Recognizes and is tolerant of differences in people
o Works to assure everyone is at the same point of understanding before moving forward
o Takes the time necessary to assure everyone fully understands their role in the project or activity
o Follows established processes and change control procedures when implementing change
Perseverance
o Pursues everything with energy, drive, and a need to finish throughout entire duration of a project or activity
o Seldom gives up before finishing, especially in the face of resistance or setbacks
Influencing
o Builds support for ideas
o Gains cooperation from others to obtain information and accomplish goals
o Actions are adapted to specific audiences
o Influences through others
Business:
Action Oriented
o Proactive about making things happen
o Identifies opportunities for improvement or change and moves forward
o Does not wait to be assigned tasks
o Enjoys taking on new challenges
Customer Focus
Leadership
Drive Deployment
o Communicates team goals with clarity and focus
o Provides expertise to achieve project goals
o Holds others accountable for results and continuous improvement
Pursue and Apply Learning
o Demonstrates a curiosity for trying new things
o Continuously develops own leadership capabilities
o Communicates and applies lessons learned.
o Coaches and mentors employees
Experiences/Education
Required:
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:
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
Nesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.
Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.