Berkshire is the global contamination control leader for clean room and controlled environment consumable products. We provide customers with technically advanced materials aimed at application performance. We focus on total solutions that consistently minimize the risk of product and process contamination. With our customer relationships we continuously focus on complete engineered clean solutions. For over 55 years Berkshire has understood and delivered world class manufacturing, reliable supply chain, highest standards for quality, technically advanced products assuring mutual success each step of the way.
The ideal candidate will be strategic minded, be a team player that can also work independently with a positive attitude, be proactive, manage complex tasks and problem solve, and possess a high attention to detail. The
Quality Engineer must have the ability to collaborate with peers and management and demonstrate exceptional judgement and a high degree of professional maturity while modeling loyalty, integrity, and honesty.
Qualifications
- Bachelor’s degree from a four-year college or university in Engineering or Science
- Must have Process Validation Experience
- Strong analytical, critical thinking, and problem-solving skills including 8D’s
- Proven knowledge of Quality Systems Standards and have extensive experience in a quality assurance environment
- Considerable experience in sterile manufacturing and an understanding of the sterilization process and its impact to products
- Strong computer experience with Microsoft Excel and Power Point and the ability to develop reports, spreadsheets, and presentations required
- Possess excellent verbal and written communication skills and have ability to communicate and work well with all levels of the organization
- Able to work efficiently in a team environment and perform responsibilities with minimal supervision
- Demonstrate a positive attitude in the face of challenges
- Maintain a high attention to detail and ensure compliance to standards
- Ability to maintain confidentiality in matters involving security and/or manufacturing
- Ability to multi-task, manage diversity, and facilitate effective problem solving and resolution
- Willingness and initiative to remain current in skills and industry trends
- Willingness and ability to work off shift and weekends, if necessary
- Textile industry (yarns, knitting, finishing) Knits and Nonwovens is preferred
- Experience working with ISO 9001:2015, GMP and FDA regulations is preferred
Essential Job Duties
- Responsible for monitoring and testing the quality of products throughout the manufacturing process, ensuring they meet established company and industry standards by identifying issues, recommending solutions, and implementing quality control systems to maintain product consistency and customer satisfaction.
- Define and enforce quality standards for products, processes, and raw materials to ensure adherence to relevant quality standards and regulations (i.e., GMPs, ISO9001, and FDA 21 CFR Part 820).
- Create and implement methods to inspect, test and evaluate the reliability of manufacturing processes, and production equipment.
- Conduct product testing and inspections at various stages of production to identify defects and non-conformances.
- Create and maintain detailed quality documentation including test procedures, inspection reports, corrective actions, and non-conformance reports.
- Determine, track, and trend quality key performance indicators (KPIs).
- Collaborate with production, engineering, and management teams to identify and implement process improvements to minimize quality defects and optimize production efficiency
- Coordinate with validation personnel to prepare, compose, and execute qualification protocols (IQ/OQ/PQ)
- Participate in internal and external quality audits.
- Ensure site compliance with all applicable Quality trainings.
- Evaluate and select suppliers based on quality standards, conduct regular audits to ensure compliance with ISO and company/customer requirements.
- Identify and mitigate risks associated with product quality, including conducting root cause analysis and implementing corrective actions.
- Work closely with cross-functional teams, including procurement, production, and product development, to ensure quality issues are addressed promptly and effectively.
- Drive continuous improvement initiatives to enhance quality and reduce defects and non-conformances.
- Provide training and support to internal and external customers and suppliers on quality standards and expectations.
- Perform other duties as assigned by the Quality Manager.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
PHYSICAL DEMANDS
- Ability to occasionally lift and/or move up to 20 pounds
- Close vision
- Frequent walking/standing
Benefits
- Medical
- Dental
- Vision
- Life Insurance
- Voluntary Life Insurance
- Short- and Long-Term Disability
- Flexible Spending with Company Match
- 401(k) Retirement Savings Plan with Company Match
- Paid Holidays
- Paid Vacation
- Personal/Sick
- Tuition Reimbursement
These statements are intended to describe the general nature and level of work being performed by employees assigned to this job. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this job.
An Equal Opportunity Employer
www.berkshire.com
About Berkshire Corporation
Berkshire is the global contamination control leader for clean room and controlled environment consumable products. We provide customers with technically advanced materials aimed at application performance. We focus on total solutions that consistently minimize the risk of product and process contamination. With our customer relationships we continuously focus on complete engineered clean solutions. For more than 55 years, Berkshire has understood and delivered world class manufacturing, reliable supply chain, highest standards for quality, technically advanced products assuring mutual success each step of the way.
