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 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.
Your Role: The Quality Engineer II will participate in the creation and review of technical product literature and customer facing documentation. This is a new position supporting the Jaffrey NH manufacturing site and will collaborate with key members of the division to ensure product literature is accurate and routinely reviewed for compliance to company and industry standards.
Essential Job Functions:
- Create / Revise technical product literature and customer facing documentation. Review and compare content to product specifications, technical publications, and validations to ensure data is complete and accurate.
- Responsible for conducting routine reviews of documents to ensure data is accurate and meets current company and industry standards.
- Participate in cross functional team(s) to improve current literature content and the creation / approval process.
- Other tasks as assigned to support the program and device manufacturing workcenters
Who You Are:
- BS degree in a scientific/technical discipline – Engineering preferred.
- Advanced degree (MS of MBA) a plus.
- Minimum of 3 years’ Quality Engineering experience in a FDA regulated (pharmaceutical, biotechnology, or medical device) manufacturing setting with proven track record of successful performance.
- Understanding or experience with ISO & FDA regulations (such as 21 CFR 820, 210 & 211) a strong plus.
- Demonstrated ability to create and update standard operating procedures (SOP) and other technical documents.
- Working knowledge of Electronic Quality Systems (CAPA, Change Control, Documentation Management)
- Black Belt or Green Belt a plus
- CQA or CQE a plus
- Travel Requirements: Travel to other MilliporeSigma locations is required (~ 20%).
- Other Requirements:
- Proven strong influencing skills w/ ability to motivate, inspire, and negotiate with internal and external teams to achieve goals and objectives.
- Strong written and verbal communication skills are a must. Able to collaborate at all levels and functions of the organization and with customers.
- Ability to operate in a complex, matrixed, and fast paced environment.
- Sufficient experience to make risk-based decisions.
- High intellectual horsepower and proven problem-solving ability. Good decision maker.
- Collaborative and motivated team player. Always looking to share and advance best practices.
- Ability to drive change and challenge the status quo in a respectful/professional manner.
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 come2emd.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 his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.