Quality System Engineer - Nc/capa & Temporary Deviations
Mölnlycke Health Care AB / Administratörsjobb / Göteborg
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If you're ready to have an impact in a career that makes a difference, Mölnlycke could be your next step. You'll be helping to equip medical professionals around the world with solutions to improve outcomes for patients. And you'll be developing yourself in a global environment with an inspirational culture, with lots of opportunities. All the while building a successful career, with real purpose.
Mölnlycke is now looking for a Quality System Engineer - NC/CAPA & Temporary Deviations to join our Quality Systems team. This role will be placed at our global HQ, Gothenburg Sweden. The aim of this role is to support and coordinate the global non-conformance/CAPA and temporary deviations process across the business.
Your tasks will include two main processes:
NC/CAPA (process):
Support HQ NC/CAPAs from initiation to closure.
Support the biweekly NC/CAPA coordinators team meeting.
Support the monthly CAPA Review Board meetings.
Support /maintain HQ/global reporting.
Increase compliance and alignment of NC/CAPA process across the business.
Work with QA Business owner to continuously improve the MasterControl NC/CAPA Management platform.
Temporary Deviations:
Support temporary deviations from initiation to closure.
Support /maintain HQ/global reporting.
Increase compliance and alignment of the Temporary Deviations process across the business.
What you'll get
Competitive compensation package including company pension plan, bonus, company health care
Wellness benefits
Flexible working hours and flexible work from home policy
Great colleagues in a global company
An open, friendly and fair working atmosphere
What you'll need
Capabilities:
Ability to communicate effectively across all levels of the organization.
Result orientated and performance driven with a strong customer oriented and problem-solving mindset.
Team player, patient and customer focused.
Qualifications & Experience:
Experience in working directly with NC/CAPA and/or manufacturing within the medical device or Pharma industry is a distinct advantage.
Academic background
Experience in working within Quality assurance, Quality Management Systems. International experience preferred.
Experience in regulations and standards affecting Medical Device and pharma (recommended ISO13485, MDD/MDR, 21 CFR part 820).
Fluent English skills
Our approach to diversity and inclusion
We strive to have a diverse mix of people from different cultures, ages, geographies and genders, to reflect the world in which we operate and to facilitate innovative thinking across the business.
Please apply at earliest convenience, we are continuously reviewing applications.
About Mölnlycke
Mölnlycke is a world-leading medical products and solutions company that equips healthcare professionals to achieve the best patient, clinical and economic outcomes.
Our business is organised in the four business areas Wound Care, Operating Room Solutions, Gloves and Antiseptics, where customer centricity, sustainability and digitalisation are at the heart of everything we do.
Mölnlycke employs around 8,700 people. The company headquarters are in Gothenburg, Sweden and we operate in more than 100 countries worldwide. Mölnlycke is a founding partner of GoCo Health Innovation City, a world-class innovation cluster for health, and in early 2025 our headquarters will move there.
Since 2007, the company has been part of Investor AB, an engaged owner of high-quality, global companies which was founded by the Wallenberg family in 1916. For more information, please visit
www.molnlycke.com and
www.molnlycke.com/career Så ansöker du Sista dag att ansöka är 2024-01-01
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare Mölnlycke Health Care AB (org.nr 556547-5489)
Gamlestadsvägen 3 C (
visa karta)
402 52 GÖTEBORG
Arbetsplats Mölnlycke Health Care AB
Jobbnummer 8290376
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