Quality Manager is responsible for the day-to-day operations in accordance with the Director of Quality, of all quality activities, as defined by the quality management system, ISO 9001 requirements, current and future certifications, and accreditations. The Quality Manager is responsible to provide support and guidance to the quality associates. This key position will advise leadership on necessary continuous improvement efforts so that systems and processes are in line with overall company strategy, voice of the customer, regulatory standards, guidelines, and quality policy. The QM provides technical input, advises, and implements necessary process and documentation changes. This role will interface with manufacturing, materials, client services, logistics and warehouse departments. This role will manage and perform critical quality tasks as needed to for the business operations.

Duties/Responsibilities:

Your responsibilities as a Quality Manager will include but not limited to:

  • Manage the process to inspect, test and evaluate single use assemblies and products
  • Ensure that processes and single use assemblies adhere to quality standards
  • Track products through the manufacturing process to guarantee that each part of the process is correct
  • Perform detailed and recorded inspections of final products so the products are up to industry and company standards
  • Manage and maintain overview of all external customer complaints
  • Along with the Director of Quality manage the CAPA process. Follow-up and verification of CAPAs to assure no recurrence. Facilitate the closures of NCRs in a timely manner and adhere to corporate escalation and reporting guidelines
  • Support QMS to meet ISO 9001 requirements; identify and maintain the specific standards
  • Manage the responses to customer questionnaires, certification requests and surveys; prepare and maintain/update standard responses
  • Support customer audits and be the quality contact for customer and supplier questions
  • Participate as the Change Control Board Member for Quality
  • Participate in Drawing Review Meetings as the Quality point of contact
  • Prepare and approve material specifications for raw materials, distributed products and other HPNE products
  • Prepare and approve SOP that support the quality process
  • Performs through batch record review prior to accepting product lot for release
  • Other projects and duties as assigned for the overall benefit of the organization

Required Skills and Abilities:

  • Must have a strong attention to detail
  • Strong knowledge of quality system rules and regulations
  • Strong interpersonal and organizational skills
  • Batch record documentation and review preferred
  • Experience with the NCR process
  • Experience with reading engineering drawings
  • Ability to take initiative, maintain confidentiality, meet deadlines, and lead people in a team environment essential
  • PC skills required (MS Word, Excel, PowerPoint, Access)
  • Cleanroom experience is a plus

Education and Experience:

  • Bachelor’s Degree in a life science discipline, or an equivalent combination of education and experience; formal training and/or advanced courses are preferred
  • 5 years progressive work experience in quality systems, combined with a demonstrated record of accomplishments as a quality professional, and with strong customer orientation in a similar industry; previous supervisory experience required

Physical Requirements:

Typically works in an office environment with adequate lighting and ventilation and a normal range of temperature and noise level. Although this position primarily works in an office environment, while performing the duties of this job, the position can be exposed to a warehouse environment where there are vehicles and a noise level in the work environment can be loud.

Minimal physical effort is required. Work is mostly sedentary but does require walking, standing, bending, reaching, lifting, or carrying objects that typically weigh less than 30 lbs.

High Purity New England is an equal opportunity employer.

 

If you would like to apply for this role, please send your resume, cover letter, and a brief message detailing the role you are applying for to [email protected]