Quality Engineer

Quality Engineer

Reporting directly to the Quality Assurance and 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

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 IV. PERFORMANCE MEASURES AND STANDARDS

Quality Improvement

Perform root cause investigation and CAPA (corrective action preventative action) to deliver non-repeatable issues, measure effective performance of CAPA solutions.

Develop, lead and drive optimization Kaizens related to top quality losses.

Lead data collection, analysis and assignment of standard Quality loss trees in support of operational KPI reporting.

Support the development of PFMEA documents, perform risk assessment and updated PFMEA documents for equipment and processes as needed.

Partner with department leaders to execute validations and provide support for validation including report writing, and participation. ISO Documentation

Create new SOPs and modify current SOPs using the established structured format; which will allow for production operator to perform and produce the same outcome every time the process is executed. ISO Management System

Leads, develops and manages the layered process audit program.

Manage and ensure compliance with the quality management system through communication, training and internal/external audits.

Assess training and development needs related to the quality program.

Ensure that all training activities associated with validation activities are performed in a timely manner.

Implement and verify site calibration and maintenance program for inspection, measuring and testing equipment. Coordinate performance of quality measurement equipment capabilities studies.

Initiate and support Management of Change (MOC) per requirements.

Support the documentation of maintenance procedures to ensure the production of quality products. Provide insights to trends and performance of processes through data analysis.

Support efforts to implement and maintain the all company certification and regulations including, SQF, ISO 9001, ISO/IEC 17025, and RC14001/EHS&S management system; Innovation

Support innovation funnel activities with key customers by partnering with process engineering and operations departments to support IQ/OQ/PQ processes.

Develop timely validation and test protocols for new processes, computer software, or equipment in conjunction with the engineering group.

Establish and maintain systems to maintain raw materials, finished goods within specification.

Supports and participates in structured quality improvement activities related to customers, consumer issues/complaints and PQ gaps. Peter Cremer Training Required

We will follow the company written training program for this position. Customer Service, Teamwork & Code of Conduct

Maintain a safe, legal and environmentally protective operation

Listen to our customers, suppliers and employees

Respond quickly to customer concerns

Follow set guidelines for GMP, quality and food safety requirements

Maintain training on applicable procedures in quality, GMP, and food safety

Report any food safety, security, and / or quality issues to management or the HACCP team to initiate action

Provide flexible and innovative strategies to support new business opportunities

Be cost effective in the utilization of our resources, thereby contributing to the profitability of Peter Cremer North America, LP and our customers

Strive for continued improvement

Willing and eagerness to learn

Maintain positive attitude.

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.