Team Lead Product Complaints
Mölnlycke Health Care AB / Kemiingenjörsjobb / Göteborg
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hela Sverige Visa alla jobb hos Mölnlycke Health Care AB i Göteborg 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 while building a successful career, with real purpose.
Mölnlycke is now looking for a Team Lead Product Complaints to join the Global Quality organization.
About the job:
The purpose of this position is to ensure patient safety by providing a comprehensive and effective product complaint handling, trending and incident reporting.
You'll be an ambassador for the team and together with the Global Product Complaints Manager drive as well as develop the vigilance and product complaints handling competence within the entire Mölnlycke organisation.
Together with Global Product Complaints Manager you'll decide on actions to be taken to comply with regulatory and vigilance requirements, including corrective actions related to audits and Global CAPA. You'll provide input and recommendations for decision making concerning Product Complaints Handling and Incident Reporting.
Within primary focus areas this role also has the following key accountabilities:
Lead and coach the Product Complaints Specialist Team in order to secure optimal resource planning and a stimulating environment.
Together with the Global Product Complaints Manager and the Lead Product Complaints Specialists lead the activities required for Product Complaints Handling.
Responsible for providing input and documentation of regulatory assessments and reportability decision of complaints in EU, as well as performing the submission of relevant incidents to NCAs according to MDR.
Take initiative and lead in improving of existing process and/or developing of new processes. Ensure suggested improvements are implemented.
Provide input for interactions with external stakeholders e.g. Competent Authorities and Notified Bodies regarding complaints, incident reporting and other product quality issues.
Actively contribute to increased complaints handling knowledge within the entire organization. Identify training needs for stakeholders/roles involved in the Product Complaints Handling Process.
What you'll need...
To be successful in this role you'll need to be a strong team builder with high flexibility, a positive attitude and able to lead and motivate people in a challenging environment.
You'll need excellent communication and networking skills, being comfortable in facilitating discussions, taking decisions and/or making recommendations to key stakeholders.
You'll also need high integrity, a strong performance drive, willingness and ability to take ownership.
Preferred background:
Academic background in life sciences, , quality management or regulatory affairs.
Quality Management system
Knowledge of ISO 9001, ISO 13485, US FDA 21 CFR part 820
Knowledge of MDD/MDR
Good Distribution Practice, GDP, Good Pharmacovigilance Practice, GVP
>3 years experience of handling complaints and incident reporting preferably in a leading position.
Experience from work in an international environment.
Quality, regulatory and process knowledge within in medical devices and/or pharmaceuticals with post-marketing surveillance, complaints handling and/or voice of customer experience.
A clinical background and manufacturing/technical/product knowledge would be advantageous.
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
Your work-life balance
We have a flexible work from home policy.
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.
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 8,400 people. The company headquarters are in Gothenburg, Sweden and we operate in more than 100 countries worldwide. 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/careers If this sounds like you and you feel you have what it takes to succeed in this role, we want to hear from you! Please apply at earliest convenience, we are reviewing candidates continuously.
www.molnlycke.com/careers Så ansöker du Sista dag att ansöka är 2023-06-21
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 7802004
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