Quality Engineer - Gibbstown, United States - Keystone Industries

Keystone Industries Gibbstown, United States

4 weeks ago

Description

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

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 required.

Schedule:

8:30 am - 5:00 pm, M-F

with flexibility.

This position is

100%

ONSITE
in an industrial setting

Location:
Gibbstown, NJ

*

Position Overview *

The Quality Engineer is responsible for leading and executing validation activities for new or existing products and processes, ensuring compliance with regulatory standards and quality requirements.

This individual is the point of contact for troubleshooting/problem solving of quality upsets, significant product change projects, and continuous improvement of existing processes.

Essential Functions

Lead the implementation of quality related activities for new and/or existing products or processes.

Lead validation efforts for manufacturing processes, equipment, and systems, including developing IQ, OQ & PQ protocols, compliant with existing SOPs.

In collaboration with other personnel, develop and write CAPAs, NCRs, process deviations, and other quality documentation to ensure quality and efficient production of regulated products.

Manage changes to manufacturing processes, equipment, or materials in compliance with FDA regulations and company procedures. This includes assessing the impact of changes, obtaining necessary approvals, and updating documentation accordingly.

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 cross-functional support by sound and timely decision-making utilizing statistical and problem-solving tools.

Contribute to the design for the manufacturing of new products.

Lead root cause analysis and corrective actions to establish plans to reduce cost of poor quality.

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

Keep management informed on project status and significant quality issues.

Act as the point of contact for troubleshooting/problem solving of quality upsets.

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.

Manufacturing and/or laboratory experience with any of the following preferred: FDA regulated products, OTC, Medical Device.

Knowledge of cGMP requirements and ISO standards

Experience with developing and writing validation plans and procedures.

Knowledge of IQ/OQ/PQ protocols.

Strong problem solving and critical thinking skills.

Ability to navigate ambiguous situations; flexible.

Collaborative attitude and strong interpersonal skills - ability to interface and communicate/collaborate at all levels internally and externally.

Strong organizational and decision-making skills.

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

Computer proficiency including Microsoft Office Suite, Smartsheet, ERP systems, etc.

Desired Skills

Cleanroom experience.

Prior QMS experience.

Ability to create and conduct training on various topics from small to medium audiences.

*

Education *

Bachelor of Science or Higher in Chemical or Mechanical Engineering, Chemistry, or related discipline.

*

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

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