A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
Under management supervision, the Quality Engineer is directly responsible for maintaining the quality system in compliance with Company procedures and regulation standards; providing GMP support for all operations; supports the audit process.
In this role you will; review Manufacturing and Productions Device History Records (DHR’s) to ensure compliance with quality system and regulatory requirements, performs project reviews/audits for Device History Files (DHF’s) to ensure compliance with quality system and regulatory requirements, establishe and maintains procedures for work instructions and other forms as needed to meet the quality system requirements, performs IQ, OQ and PQ for equipment or process validations as required, quarantine and monitor the disposition of nonconforming product in support of deviation investigations, and coordinates MRB meetings, conducts deviation, CAPA, PA and audit investigations as necessary for determination and implementation of corrective and preventive actions.
This role supports the ongoing compliance of routine equipment maintenance and calibration activities, performs monitoring and measuring activities as assigned for processes as related to quality control and regulatory issues, contributes in maintaining a quality system that is compliant with the ISO 13485, Canadian MDR requirements, FDA CGMP standards, foreign country product registrations, and CE Mark to comply with European Union IVDD; Participates and conducts periodic internal audits according to required schedules, provides process data to create QA metric to assess the quality systems performance and efficacy. Additionally; you will need strong interactive skills in general communication, cross-functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, and be able to coordinate with cross-functional team members. A Quality Engineer I must have strong technical problem-solving skills, mechanical and electronic ability aptitude to assist with equipment trouble-shooting, be able to demonstrate the ability to communicate effectively both verbally and in writing. You will perform other duties as may be determined to serve the organizational capacity to best serve our customers.
Who You Are:
- An undergraduate degree in a biological science or equivalent life sciences degree
- 3+ years’ experience with PC software applications (MS Word, MS Excel, and Adobe)
- 1+ year experience with FDA QSRs cGMP, AND ISO 13485 industry standards is required
- Experience with SAP and Trackwise highly preferred
- 2+ years’ experience in Quality Assurance/Quality Control preferred
- 2+ years’ experience in an FDA/ISO or other regulated environment is preferred
- General understanding of the principles and practices of managing a product line from research and development phase all the way to distribution is preferred
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.