JOB TITLE:
Supplier Quality Engineer
ABOUT US:
Cold Chain Technologies is a leading global provider of advanced thermal packaging assurance products, digital solutions and services for the transport of temperature-sensitive material, principally serving the pharmaceutical, biotech, diagnostics, health care and medical device industries. With more than 50 years of experience in ensuring product safety in transit, CCT has built a reputation as the industry's most innovative and reliable provider to the largest global life sciences companies and has had a history of vigorous growth. CCT today has the broadest portfolio of products, including the largest digitally enabled parcel shipper fleet in the industry. CCT also leads the industry in offering high performing, sustainable solutions, replacing fossil fuel-based materials.
The company’s headquarters is in Franklin, MA, and is ISO 9001: 2015 registered. CCT has additional facilities in Nashville, TN, Center Valley PA, Elgin, IL, Dallas TX, and San Diego, CA. CCT is also manufacturing and distributing products in Europe, Latin America and Asia, with significant growth coming through international expansion. CCT’s design and ISTA-certified testing laboratories are universally recognized throughout the industry as world-class.
Job Description
The Supplier Quality Engineer will report to the Global Supplier Quality Senior Manager. They will be responsible for all quality compliance activities relating to third party manufacturer/service providers, software developers and other suppliers. In this role they will manage qualification and surveillance audits of suppliers as assigned, managing lifecycle of supplier nonconformances and the Supplier Corrective Action (SCAR) process, and collecting, assessing and reporting on supplier quality data.
Primary Responsibilities:
- Interface directly with suppliers, partners and software developers to develop and implement product and/or process controls required so that supplied material and services meet all requirements.
- Full engagement and ownership in resolving supplier quality issues per quality system requirements and use of the Supplier Corrective Action Process.
- Maintain suppliers’ compliance (updated certificates on file, perform suppliers re-evaluation)
- Onboarding of new suppliers per procedure.
- Perform both Quality System and Product Quality supplier audits.
- Documents and follows up on audit results and required actions to be addressed by the supplier.
- Develop, assess & optimize supplier process as needed.
- Participate in Material Review Board (MRB) review of nonconforming product; recommend disposition and corrective action
- Track, analyze, and report on supplier performance metrics to stakeholders along with recommendations for tactical and strategic improvements
- Actively participate in the assessment and improvement of quality system processes with emphasis on supplier development/quality
- Represent Quality function on New Product Introduction Teams/
- Represent Quality and provide governance and oversight for the software release processes.
- Actively support Health Safety and Environmental rules and regulations.
- Other duties as assigned
Qualifications and Requirements:
- Bachelor’s Degree or higher preferred; ideally in a related scientific discipline
- 3-5 years’ experience in a quality role, ideally in an ISO 9001:2015 or pharmaceutical manufacturing environment.
- Trained/certified ISO 9001:2015 supplier quality auditing experience
Strong verbal and written communication skills, including the ability to write technical reports / presentations.
- Solid organizational and follow-up skills, as well as attention to detail.
- Critical thinker with analytical problem-solving skills, able to resolve quality-related issues in a timely and effective manner.
- Understanding of various process-improvement methodologies, such as Six Sigma and Lean Manufacturing.
- Knowledge of nonconformance, CAPA, and other standard compliance systems.
- Proficiency in Microsoft Office and job-related computer applications required.
- Strong Collaboration Skills.
- Ability to work as part of a cross functional team.
- Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance.
- Demonstrated ability to drive the completion of tasks.
- Proven decision-making capability with accountability and responsibility.
- Effectively manage multiple and changing priorities.
- Ability to work in a very fast-paced environment.
- Ability to lift 50 lbs. on occasion.
- Work related travel required – domestic and international (up to 50%)
Other Requirements (License, Permit, Certification, Travel, Physical etc.):
- Working knowledge of cGMP and GDP preferred
- Experience in software quality processes, governance and oversight.
- Project Management (conducting status meetings, project reporting, etc) is a plus.
- Six Sigma Green Belt or Lean Certification
