Quality Engineer

Company Overview:

We are passionate about our employees. We strive to create an environment that is stimulating and motivating and a culture that fosters mutual respect, teamwork, and career development. Come join the Keystone team so we can build your career together!

In addition to competitive starting salaries, we offer a wide variety of competitive benefits, perks and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Please visit our website at www.keystoneind.com to learn more about Keystone Industries and career opportunities.

Position Details:

• Title: Quality Engineer

• Ideal Candidate: The ideal candidate for this role will have at least 5 years' experience in product/process quality in a regulated, manufacturing environment. Degree in Engineering, Chemistry, or related field required.

• Schedule: 8:30 am - 5:00 pm, M-F with flexibility.

This position is 100% ONSITE in an industrial setting

• Location: Gibbstown, NJ (08027)

Position Overview

The Quality Engineer is responsible for ensuring that Keystone products meet all quality standards and customer requirements by integrating quality processes and monitoring key performance indicators. The quality engineer plays a critical role during the onboarding of new or modified products and/or manufacturing processes and in the troubleshooting/problem solving of quality upsets. The Quality Engineer will work closely with cross-functional teams to identify areas for improvement, develop solutions, and drive continuous improvement initiatives throughout the organization.

Essential Functions

• Collaborate with process engineers during the authoring of URS, equipment qualification and process validation protocols, forms, and reports. Analyze data and documentation in support of the development of validation strategies.

• Influence and evaluate the design for the manufacturing of new products.

• Participate in and/or lead the activities associated with batch card/process authoring and approval.

• Review and approve equipment qualification and process validation protocols, forms and reports.

• Act as quality lead for root cause analysis investigation and corrective/preventative action implementation.

• Manage projects and participate in applicable project core team(s) and extended team(s).

• Interface regularly with quality control, quality assurance, production, engineering, analytical and R&D personnel.

• Provide sound and timely decision making utilizing statistical and problem-solving tools.

• Coordinate applicable steps to verify appropriate technology/design transfer for inter-site production and/or toll manufacturing. Develop applicable quality plans and validation strategies.

• Develop quality specifications and/or process control techniques.

• Apply statistical techniques and approved inspection methods for evaluation and testing of components and products.

• Identify, recommend, and implement initiatives for the continuous improvement of processes.

• Track nonconforming material and support Material Review Board (MRB) efforts.

• Lead or participate in risk assessment activities and related documentation.

• Perform internal audits of products and processes.

• Support supplier and subcontractor audits.

• Keep management informed on project status and significant quality issues in a manner commensurate with the potential impact of the issue.

• Support future Engineering and Quality initiatives.

• Perform research as needed.

• Other duties/tasks as needed/requested by Manager.

Qualifications

• A minimum of 5 years' experience in Product/Process Quality and knowledge of validation processes in a regulated, manufacturing environment is required.

• Understanding of QMS, GXP and FDA CFR requirements

• Manufacturing and/or laboratory experience with any of the following is preferred: cosmetics, pigmented products, coatings, light-curable technology, polymers, water-based solutions (sterile, purified, preserved).

• Ability to apply principles of root cause analysis and statistical analysis to determine common vs. special causes is required.

• Ability to develop CAPA plans is highly desirable.

• Ability to apply concepts leading to improvements in quality processes is desirable.

• LEAN/Six-Sigma Training/Experience/Certification preferred

• Strong understanding of design control process including design validation/verification, process validation and design transfer.

• Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, graphs, charts, diagrams). Ability to deal with a variety of abstract and concrete variables. Ability to interpret information furnished in written, oral, or diagram form.

• Mechanical aptitude - good understanding of mechanical equipment in a manufacturing environment

• Ability to independently design experiments for troubleshooting

• Strong problem solving and critical thinking skills

• Ability to work in a team-based environment and work collaboratively to solve problems

• Excellent interpersonal skills

• Strong organizational and decision making skills

• Demonstrated Project management skills. Ability to successfully work on multiple projects simultaneously.

• Computer proficiency including Microsoft Office Suite.

Desired Skills

• Cleanroom experience.

• Prior QMS experience.

Education

• A minimum of a Bachelor's degree is required. A Chemical Engineering degree is preferred, but a degree concentration in Engineering, Life Science, Physical Science or a related field will be considered. An advanced degree or QE certification is a plus.

Physical Demands and Environments

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Physical Demands: Employee is required to walk; sit; use hands to finger, handle or feel objects, tools, or controls; reach with hands and arms; balance; stoop; bend; kneel and climb. The employee must regularly lift and move up to 15 pounds, frequently lift/move up 25 to pounds and occasionally lift/move up to 40 pounds.

• Work Environment: This position requires one to work both in an office environment and manufacturing facility. There is a moderate level of heat, cold, dust, dirt and fumes. Employee frequently works near moving mechanical equipment and chemicals. Employee will be exposed to varying temperatures.

Benefits/Perks:

• Medical, RX, Dental, and Vision Plans

• Company-sponsored Life Insurance

• Flexible Spending Account (FSA) - Medical, Dependent Care.

• 401K Plan with Employer Contribution

• Voluntary Term Life/AD&D Insurance, Short-Term and Long-Term Disability

• Accident and Critical Illness Insurance

• Pet Insurance

• Employee Assistance Program (EAP)

• Tuition Assistance Program

• Weekly Pay

• Paid Holidays

• Employee Referral Bonus Program

• Company social events throughout the year including tickets to sports events and concerts

• Free Daily Lunch

• Fitness Center onsite