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Position:
Quality Engineer & Data Analyst
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Job Id:
1548
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# of Openings:
0
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Quality Engineer and Data Analyst
Why work for us
- Competitive benefits including Medical, Dental, Vision, 401K match, and a few others!
- You are eligible to participate in Cremer's profit-sharing program. This can pay out up to 9% of your annual income.
POSITION SUMMARY
Reporting directly to the ST Quality & Lab Manager, this position uses critical thinking and technical writing skills to research, develop and document key quality processes such as process and software validations, procedures, risk assessments, PFMEAs, as assigned in a timely manner. This role supports all levels of operations, quality, laboratory, and engineering departments in the development, management and execution of testing and validation protocols. This position will service all aspects of the businesses at PCNA. This role supports the Engineering team with maintaining the facilities' master validation plan. Facilitates the company's Management of Change (MOC) process. Maintain outgoing process data for statistical analyses, trending purposes to ensure the process is maintained as validated. Continuous Improvement Coach and Coordinator. Perform data analyses using ERP, PowerBI, Excel, etc.
POSITION REQUIREMENTS
Education, Credentials, Licenses:
- Bachelor's degree in Engineering (Biomedical, Mechanical, etc), Science (Chemistry, Biology, Physics, etc.), or Math (Statistics) required
Kind & Length of Experience:
- Minimum of 5 years of experience in an industrial manufacturing environment with a quality system designed to meet the requirements of the FDA Quality System required
- Proficient in Microsoft Office is required
- Statistical tools R-Studio, JMP, SQL, ect experience is required.
- GMP in Cosmetics or Pharmaceuticals experience is preferred
- Certifications in quality, engineering, Six Sigma, or Lean Manufacturing are preferred
- Experience with Microsoft Business Dynamics preferred
- Experience with Power BI preferred
PERFORMANCE MEASURES AND STANDARDS
- Support Behavior Based Safety program.
- Ensure that federal, state and local laws, regulations, rules and codes are observed.
- Develop timely validation and test protocols for new processes, computer software, or equipment in conjunction with the engineering group.
- Support validation activities at the sites including report writing, and participation.
- Prepare reports and maintain records in accordance with Regulatory Standards.
- Interacting and presenting validation documentation during internal and external audits.
- Produce and perform risk assessments and PFMEA documents for the equipment and processes.
- Ensure that all training activities associated with validation activities are performed in a timely manner.
- Ensure all systems are running according to necessary specifications and operate within regulations to ensure the production of quality products.
- Partner with department leaders to execute validations in a timely manner.
- Initiate Management of Change (MOC) per requirements;
- Support teams with continuous improvement problem solving skills with NCMs, and CAPAs for the company.
- Provide insights to trends and performance of processes through data analysis.
- Follow the hierarchy of controls for risk management;
- Support efforts to implement and maintain the all company certification and regulations including, SQF, ISO 9001,I SO/IEC 17025, and RC14001/EHS&S management system;
- Conform with the EHS&S Policy and the Cardinal Rules;
- Maintaining a safe and secure workplace and meet environmental site requirements;
- Support the EHS&S and Quality objectives and targets, and any specific action plans or management programs assigned;
- Report accidents and incidents to a supervisor or the EHS&S department;
- Participate in required EHS&S and Quality training.
- Other duties as assigned.
We are an equal opportunity employer. Applicants are considered for positions without regard to sex, race, color, ancestry, religion, national origin, disability, age, marital status, disabled veteran or Vietnam era veteran status, genetic information, sexual orientation, pregnancy, including childbirth or any related condition, gender identity or expression, citizenship, or any other characteristic protected by applicable state, federal or local laws.
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Apply for this Position
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Cremer North America
401(k)
Nov 12, 2024 