We are looking for a

Quality Manager

Clinton, CT, USA

Bausch Advanced Technologies Inc., a global leader in the pharmaceutical packaging machinery industry currently has an opening for a Quality Manager in our quickly expanding Bausch Consumables division at our Clinton, CT facility. Bausch Consumables is a medical device manufacturer for empty IV bags and single use fluid pathway kits. As a Quality Manager at Bausch Consumables, you will lead and expand your quality team as we are quickly growing to meet our customers’ needs. As a newer start up within an established company, you will have the ability to steer the Quality department and Quality Management System as you see fit. Our rapid expansion gives us the ability to establish and grow our teams within this division as we will also be looking to expand into a larger facility within the next year or two. This position reports to the Director of Operations of Bausch Consumables. Our division serves many of the large pharmaceutical companies that supply our hospitals with the necessary drugs to combat COVID and other serious illnesses so you and your team will be a part of this important effort.
  • Support the facility as a Quality Management System (QMS) Representative.
  • Provide leadership in the execution of Quality Systems activities and execution of the programs and processes related to CAPA, Management Reviews, Supplier Quality Management, Management Reviews, Non-Conforming and internal audits and training activities, validations, root cause analysis, etc.
  • Optimize quality systems to effectively identify, measure, and reduce cost of quality activities, where applicable.
  • Identify, support, and develop departmental resources to achieve business and quality objectives.
  • Lead and participate in all facility audits (FDA, ISO, Corporate, and Customer).
  • Supervise Quality employees in batch record product release.
  • Supervise Quality employees in support of incoming, in process, and final release product inspections.
  • Work with Manufacturing and other departments to ensure a working QMS.
  • Provide support writing SOPs as needed ·
  • Batch record creation as needed.
  • Execute risk assessments and make quality decisions on final product and any issues that may arise.
  • Other functions to support Consumables as needed.

BS Degree.

3+ years of experience in a quality control/regulatory environment with proven track record of responsibility for product compliance.

Quality Assurance/Control and/or Regulatory experience preferred.
In-depth knowledge of cGMP and FDA compliance

Familiarity with ISO 13485.

Excellent verbal and written communication skills in English facilitating the preparation of technical presentations to customers, regulatory authorities and scientific bodies as well as internal communication at all levels of the company on matters of expertise.

Exceptionally strong team and interpersonal skills

Proven track record of strong management skills

Experience in a multi-disciplinary environment, with engineering, operations, and business functions closely cooperating

Demonstrated ability to set realistic goals and timetables to execute those goals. This is a full – time, permanent position with a comprehensive benefits package – Medical, Dental, Life Insurance and 401(k) with a company match. Paid vacation, Personal and Sick days. Seven paid holidays per year.

Bausch Advanced Technologies is an Equal Opportunity Employer.

Job typeFull-time

PayFrom $80,000 per year

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