Quality Assurance Engineer

Quality Assurance Engineer

我们做什么

在 Kenvue，我们意识到日常护理的非凡力量。我们以一个多世纪的传统为基础，植根于科学，是标志性品牌的品牌 - 包括您已经熟悉和喜爱的 NEUTRGENA®、AVEENO、TYLENOL®®、LISTERINE®、JOHNSON'S® 和 BAND-AID®。科学是我们的热情所在;关心就是我们的才能。

我们是谁

我们的全球团队由 ~ 22,000 名才华横溢的员工组成，他们的职场文化中，每个声音都很重要，每一个贡献都受到赞赏。 我们热衷于洞察， 创新并致力于为我们的客户提供最好的产品。凭借专业知识和同理心，成为 Kenvuer 意味着每天有能力影响数百万人。我们以人为本，热切关怀，以科学赢得信任，以勇气解决——有绝佳的机会等着您！加入我们，塑造我们和您的未来。有关更多信息，请单击 here.

Role reports to：

Digital Engagement Lead Q&C EMEA

位置：

Europe/Middle East/Africa, France, Normandy, Val-de-Reuil

工作地点：

混合

你会做什么

Kenvue is currently recruiting for:

Quality Assurance Engineer

This position reports into EMEA Q&C Digital Lead and is based at France/Germany/Italy.

What we do At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent.

Who we are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage - and have brilliant opportunities waiting for you! Join us in shaping our future-and yours. For more information, click here.

Role reports to: EMEA Q&C Digital Lead

Location: France, Germany, Italy

Travel %: 10%

What you will do

The Quality Assurance Engineer is responsible for ensuring compliance with quality agreements and regulatory requirements in EMEA, focusing on the Review by Exception (RBE) project. The SME will review quality dossiers against Process Validations, SOPs, WIs, and the practice on sites, leading compliance risk identification, and ultimately ensuring processes are compliant and aligned with quality dossiers. The SME will also provide guidance and support to multiple project stakeholders and local sites where changes, including standardizations, are required prior to the digitization of these processes.

Key Responsibilities

· Review current operating procedures (SOPs, Wis, validations etc) against quality dossiers and regulatory requirements and classify risk level of any potential deviations

· Lead, coordinate and facilitate registered dossiers versus site practices remediation plan under Arete Compliance project to eliminate compliance gaps and risks.

· Lead and support alignment with EMEA Quality management for the remediation plan strategy.

· Lead and support creation and execution of GCCs, Investigations, CAPAs and Escalations / QRBs under Compliance project Arete.

· Provide stakeholders with timely updates on any identified risks and advise on resolutions where appropriate

· Collaborate with cross-functional teams to define, assess and redraft standard operating procedures and work instructions to align with quality dossiers for current operational practices and as future business continuity plans

· Collaborate with the QHS30 digital thread program team (global & regional) to ensure that these reviews are conducted timeously within the project schedule for digitization of processes

· Guide the adaptation of manual and semi-automatic previous processes to the new digitalized solution and new specific regulations to optimize processes and ensure compliance.

· Provide coaching to employees who own procedures as to how to assess for deviations against quality dossier

· Collaborate with EMEA Self Care Quality RRT and different functions E2E in EMEA: Regulatory, Product Reliability, R&D, Make, Make Q&C, CQ, PMOs, RMC, IM/EM sites, our regional & global SMEs, and our Quality Leadership.

What we are looking for

Required Qualifications

· University/Bachelor’s Degree or Equivalent in a relevant field

· Proven working experience in quality assurance with 2-4 years of experience in QC testing and/or the QA release process

· Strong understanding of Regulatory Requirements and GxP practices

· Strong investigation, CAPA and change control experience

· Solid understanding of the full compliance life cycle

· Highly skilled in communication, both verbal and written

· Excellent stakeholder management and influencing skills

· Excellent organizational skills

Desired Qualifications

· Strong knowledge of EU, FDA and any other relevant regulatory bodies for EMEA region

· Experience in a Manufacturing setting

· Excellent problem-solving skills and attention to detail

· Experience with project management software / tools

· Experience with Investigation, CAPA, Change control tools i.e. Symphony

· Ability to collaborate and coordinate cross functional teams

· Ability to work with a large team and in a dynamic environment

· Ability to lead and coach employees in quality assurance practices

What’s in it for you

· Annual base salary. This takes into account a number of factors including work location, the candidate’s skills, experience, education level & other job-related factors.

· Paid Company Holidays, Paid Vacation, Volunteer Time & More!

· Learning & Development Opportunities

· Experience with a highly diverse and dynamic team spanning across the EMEA region

· This list could vary based on location/region

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on merit without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability

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