Senior Quality Engineer Jobs

What we are looking for:

Sr. Quality Engineer is responsible for the development, application, validation and maintenance of manufacturing and quality management systems associated with compliance to internal procedures, customer requirements and applicable regulatory standards for products and components.

Responsibilities:

• Supports customer and/or third party audits as required.
• Provides technical assistance to internal team on statistical data analysis utilizing statistical software (Minitab and Excel).
• Performs and documents Change Control Request (CCR) assessments, Corrective and Preventive Actions (CAPA) investigations, 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.
• Performs product support for product development and commercial products (reviews/approves product specifications, customer drawings, product validations protocols).
• Lead internal team during customer technical assessments initiatives.
• Act as quality SME during contract, agreement review and cross functional department initiativ
• Lead development and implementations of statistical methods and designs of experiments to support process control and process/product improvement.
• Lead continuous improvements of inspection methods and sampling plans, with a focus on human error risk elimination
• Lead development and implementation of methods for sampling, inspection, testing and evaluation of products.
• May be trained as an auditor and perform quality audits.
• Primary lead for Quality Department and approver of associated documentation for the development, execution, and approval of validation strategies, with the goal of highly capable processes, that result in high yield and enable scalability
• Lead development and implementation of quality initiatives and Key Performance Metrics
• Participate in Risk Management activities with internal team applying expertise in failure modes associated with production and production related processes risk management tools to create pFMEAs (Process Failure Mode and Effect Analysis), etc.).
• Design and/or performs physical and visual Test Method Validation/Gage R & R activities by developing and executing protocols for new or existing processes.

Qualifications:

• Intermediate to advanced knowledge of MS Office Suite and statistical software, Minitab experience preferred
• Knowledge of ISO 17025 and FDA Regulation 21 CFR Part 820 is a distinct advantage
• 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 project organizational skills required
• 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.
• Bachelor’s degree in Engineering or Quality is preferred
• Must be a Certified Six Sigma Green Belt. Certified Six Sigma Black Belt strongly preferred
• Excellent customer service focus and professionalism.
• Strong problem solving and analytical skills, with concentration on risk analysis;
• 8-10 years with Bachelors degree in Engineering and/or Life Science OR 6-8 years with Master’s degree in Engineering and/or Life Science. Relevant experience must be in life sciences/GMP industry in one or more of the following functions: Quality Assurance, Quality Engineering, Validation, Product Development, Process Engineering or Manufacturing Engineering
• Strong Supervisory skills
• Demonstrated ability to participate in and/or lead cross functional teams, ability to independently prioritize and execute projects and responsibilities.
• Knowledge of applicable regulatory standards, specifically ISO 13485 or possess the ability to understand and enforce the practices.
• Knowledge of statistics, design of experiments, sampling, gauge R&R, FMEA/risk management and process control.

Who we are:

The Secant Group is an advanced technology biomaterials company headquartered in Telford, Pennsylvania, with manufacturing facilities in Quakertown and Perkasie, Pennsylvania. Secant provides innovative solutions through next-generation materials, structures, textile designs, and process technologies for the medical device, pharmaceutical, aerospace and energy markets.

Secant Group is an Equal Opportunity Employer. We maintain a commitment to providing equal access to employment. We value diversity and encourage applications from all genders, members of minority groups, LGBTQ individuals, veterans, and disabled individuals.