Quality Engineer – Cold Chain Technologies, Inc. – Holliston, MA, USA
Cold Chain Technologies (CCT) is a leading developer and manufacturer of controlled-temperature distribution solutions for the pharmaceutical, biotech, health care and medical device industries. We are a technically advanced, financially secure company with more than 40 years of experience and a history of vigorous growth. Primarily US-based, the company has begun aggressive expansion into international markets.
The company’s headquarters are in Holliston, MA, and CCT is an ISO 9001:2008 registered firm. We have US manufacturing facilities in Holliston, MA, Nashville, TN and Reno, NV. Internationally, we are distributing and manufacturing our products in Europe through our Netherlands licensee, Topa Verpakking, and are distributing in Latin America through our affiliate, CCT de Panama. Our design and testing laboratories are highly recognized throughout the industry as world-class.
We are currently seeking an experienced Buyer/Planner to work under the direction of our Director of Supply Chain.
Under the direction of the Director of Quality Assurance and Regulatory Affairs, perform quality engineering duties including, manufacturing support, quality monitoring, problem solving, process improvement, CAPA management and internal/external auditing.
- Drive the identification, implementation, and use of statistical methods throughout the plant. Statistical methods include Statistical Process Control (SPC), Designed Experimentation (DOE), and acceptance sampling among others.
- Establish, monitor, analyze, and report on the major quality indicators for the plant. Utilize accepted capability indicators (CP, Cpk, PPM, etc.).
- Create and facilitate problem-solving teams; including the use of problem solving tools such as FMEA
- Investigate, analyze, develop and determine processes and process improvements existing products to improve quality and or productivity
- Develop and implement quality tools in the line such as defect tracking, random audits, verification check sheets, etc.
- Assist Quality Director in establishing, implementing and maintaining the quality management system.
- Responsible for continual improvement activities to enhance the quality system, such as 5S, Kaizen lean methods, etc.
- Plan and implement projects improve quality control and monitor internal quality
- Conduct audits, including closing out audit findings, creating audits finding reports and determine proper corrective and preventive actions.
- Analyze failure, corrective and preventive action to respond to customer complaints.
- Interface with external customers and suppliers on quality-related issues
- Create and maintain company quality documentation, such as quality manuals, quality procedures, etc.
- Continuously improving QA receiving inspection process and procedures.
- Ensure timely resolution of supplier failure, corrective actions and preventive actions.
- Manage suppliers’ performance and conduct audits.
- Perform duties in accordance with established quality standards
- Actively support Health, Safety and Environment rules and regulations
- BS in a science discipline; engineering degree a plus
- Min 3-5 years experience in manufacturing quality environment
- Working knowledge of ISO 9001:2008; understanding of ISO 17025 a plus
- ASQ Certified Quality Engineer or Certified Quality Auditor preferred
- Six sigma green / black belt certified and Lean Manufacturing experience
- Experience in a cGMP and FDA regulated environment
- Quality systems auditing experience; preferably as a lead auditor
- Experience in MRB, design reviews, supplier audits, corrective action programs
- Thorough understanding of QA standards, implementation and auditing
- Thorough understanding of statistical techniques and analyses
- Strong knowledge and use of MS Office applications, integrated MRP database applications, and experience with Minitab also desired
- Excellent verbal and written communication skills
- Experience in driving improvement initiatives preferred
- Ability to integrate and work well in a team environment
- Ambitious self-starter with drive to implement and achieve desired results
- Effectively manage multiple and changing priorities
- Ability to work in a very fast-paced environment
- Ability to lift 50 lbs. on occasion
- Occasional travel required
- manufacturing quality: 3 years