Based in our Quakertown, PA facility the Quality Engineer is responsible for the development, application, validation and maintenance of manufacturing and quality management systems associated with compliance to internal procedures and applicable regulatory standards for products and components.
Performs and documents Change Control Request (CCR) assessments.
Performs and documents timely Corrective and Preventive Actions (CAPA) investigations.
Performs and documents customer complaint investigations, performs root cause analysis and develops corrective and preventive actions. Works with customers to provide required technical support and information regarding the investigation.
Acts as lead on assigned CAPAs to drive corrective actions and closure of CAPA within prescribed timelines.
Completes Supplier Corrective Action Requests (SCARs) and communicates with suppliers in regards to non-conformances, supplier changes, etc.
Performs product support for product development and commercial products (reviews/approves product specifications, customer drawings, product validations protocols).
Performs statistical data analysis utilizing statistical software (Minitab and Excel).
Develops and implements statistical methods and designs experiments to support process control and process/product improvement.
Performs physical and visual Test Method Validation/Gage R & R activities by developing and executing protocols for new or existing processes.
Performs Risk Management activities utilizing risk management tools (pFMEAs (Process Failure Mode and Effect Analysis), etc.).
Supports development and implementation of methods for sampling, inspection, testing and evaluation of products.
Interfaces with customers to provide technical support for our products/complaints/change control.
Reviews/approves applicable validation and qualification documents for compliance with internal procedures (Installation Qualification (IQ), Operational Qualification (OQ), RQP, Internal Product Development Process (IPDP) phase transfer documents, Document Control Revisions (DCRs), etc.)
Supports customer and/or third party audits as required.
May be trained as an auditor and perform quality audits.
Follows established safety requirements and adheres to Health, Safety & Environmental Management System.
Performs other job related responsibilities as assigned
Adheres to GMP/QSR requirements and follows applicable QMS documentation (e.g., SOP’s, Work Instructions) to successfully accomplish job requirements.
Follows Personal Protective Equipment (PPE) policies and procedures, including wearing hearing protection, safety shoes, gloves, eye protection as required.
Follows gowning procedures in designated areas.
Skills and Knowledge:
Knowledge of applicable regulatory standards, specifically ISO 13485 and ISO 9001 (if applicable) or possess the ability to understand and enforce the practices.
Knowledge of FDA Regulation 21 CFR Part 820 preferred
Able to read, analyze and interpret common scientific and technical journals, financial reports and legal documents to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community.
Strong problem solving and analytical skills, with concentration on risk analysis;
Demonstrated project organizational skills required
Strong written and verbal communication skills.
Ability to apply principles of scientific thinking to a wide range of intellectual and practical problems; deal with nonverbal symbolism (e.g., formulas, scientific equations, graphs); deal with a variety of abstract and concrete variables.
Demonstrated ability to participate in and/or lead cross functional teams, ability to independently prioritize and execute projects and responsibilities.
Intermediate to advanced knowledge of MS Office Suite and statistical software (e.g., Minitab).
Knowledge of statistics, design of experiments, sampling, gauge R&R, FMEA/risk management and process control.
Excellent customer service focus and professionalism.
3 years' experience in life sciences/GMP industry in one or more of the following functions: Quality Assurance, Quality Engineering, Validation.
Bachelor’s degree in one or more of the following - Life Sciences Engineering, Biomedical Engineering, Quality, Life Sciences.
Requires sitting for prolonged periods of time, up to 8 hours or more a day.
Operates computer equipment, fax/copy machines, telephone, calculator and general office equipment to generate input and output and transmit data.
Occasional exposure to noisy environment where hearing protection must be worn.
Constant collaboration with Operations, Manufacturing Engineering, Product Development, Business Management/Customer Care, Quality group and peers.
Frequently collaborates with customers, vendors, suppliers, Research, Procurement, Validation and Calibration.
Occasionally collaborates with Management.