Do you want to enjoy what you do – for real – every day? If the answer is yes, you think just like us. In our daily work, we create unique medical solutions to improve quality of life. We enjoy what we do because it makes a difference in people’s lives – for real. Mölnlycke is a world leading supplier of disposable products and solutions that help healthcare professionals achieve the best patient-related, clinical and financial outcomes. We design and deliver products and solutions for wound care, pressure ulcer prevention and surgery. Our products and solutions are cost-effective, which is supported by both clinical and health economic evidence. We are now expanding the business and have high ambitions for the future. Do you want to be part of this exciting journey?
We are now looking for a Manager, Quality Engineering to play a critical role in our Regulatory and Quality Assurance team.
As a Manager, Quality Engineering, you manage a team of QA Engineers R&D, Clinical Advisor and QA consultants. Your team is, amongst other duties, responsible for:
- Ensuring all global applicable quality requirements are met within the design control process and risk management standards;
- Maintaining an effective design control process through meticulous review of current processes and ensuring they are effective and in compliance with latest regulations and standards;
- Providing guidance to R&D in product development projects and design change projects;
- Supporting R&D in handling CAPAs in a timely and efficient manner;
- Ensuring clinical and risk assessments are coordinated and executed pertaining to reportable incidents or as required by the design control process;
- Developing and maintaining relevant KPIs and metrics as required;
- Fluent in English and preferably Swedish;
- Analytical and statistical skills;
- Research / scientific / laboratory knowledge;
- Design & Development knowledge;
- Proven ability to successfully negotiate and influence towards a proactive and pragmatic outcome of complex matters;
- High EQ and proven ability to lead and motivate;
- Team player and people/customer/outcome/solution focused;
- Detailed knowledge of ISO 13485, ISO 14971, MDD/MDR and CFR part 820;
Qualifications and experience
- Academic background in medicine, medical biology, pharmacy, life sciences or engineering;
- At least ten (10) years of working experience within an international medical device company, preferably working within Quality Engineering or equivalent experience
- a minimum of three (3) years in a leadership position;
- Hands on experience in FDA and Notified Body inspections;
Closing date for applications is 6 May.
Please send your CV and cover letter to firstname.lastname@example.org
Contact Tom Bergqvist, Recruitment Partner, In-house Recruitment Services at + 46 733 872722 if you have any questions regarding this position.
We look forward to receiving your application.