Quality Assurance Specialist
Arjo AB Publ / Organisationsutvecklarjobb / Malmö
Observera att sista ansökningsdag har passerat.
Visa alla organisationsutvecklarjobb i Malmö,
Burlöv,
Lomma,
Staffanstorp,
Vellinge eller i
hela Sverige Visa alla jobb hos Arjo AB Publ i Malmö Quality Assurance Specialist
We are looking for an experienced Quality Assurance Specialist to provide QA support to product development, production and process controls, as well as feedback and monitoring activities. You will be part of the global quality systems team but will focus mainly on one product segment. The role is based at the Arjo Headquarters where the environment is international, fast-paced and dynamic. Could this be the next challenge for you?
The position
The Quality Assurance Specialist's responsibility is to support quality assurance to the entire lifecycle of a new product group. You will work closely with a variety of internal and external contacts where English will be the premiere language. You will sit locally in Malmö but work globally with other Arjo functions including software development, complaint handling, purchasing, validation, vigilance, auditing and others. During peaks, you will also provide back-up support to the global Quality Management System team with a variety of global QMS activities.
Key duties and responsibilities for the Quality Assurance Specialist
Manufacturing QA support
• Review and release of batch documentation / device history records.
Non-conformity Management
• Non-conformity handling including review and approval of concessions.
• Management and coordination of corrective and preventive actions.
Complaint Investigation
• Perform complaint investigation in cooperation with the complaint handing team, the sales and service organization and manufacturers.
Change Management
• Review and approval of change notifications.
• QA support to product / engineering changes.
Support with other activities in the Quality function, such as:
• Participation in internal and external audits
• Document control, development and maintenance of the Quality Management System
• Quality data analysis and reporting
• Purchasing controls
• Validation activities (both design and software)
• Other ad hoc coordination and admin activities
The ideal candidate
The ideal candidate has a technical background, as example Bachelor's Degree in Engineering. You have minimum 5 years related experience with Quality Management or related functions within a medical device or other regulated environment.
• Experience within other related functions, including product development, manufacturing, and operations.
• Experience with products containing software, including monitoring and wireless handling of data preferred.
• Knowledge in medical device regulations and standards, e.g. FDA's Quality System Regulation and ISO 13485:2016.
• Experience as a lead auditor is preferred.
• Experience with use of administrative software as Microsoft Office (Word, Excel, PowerPoint), SharePoint and TrackWise or similar quality process management systems.
• Strong verbal and written communication skills in English.
Some of your key characteristics include
• Ability to work independently and concurrently serving several internal clients in various matters
• Team-working skills, flexible and service minded
• Well-structured and systematic work habits.
Sounds interesting?
Please, submit your application, inclusive of CV, cover letter and transcripts no later than November 1 2018 by using our online application form. Applications will be evaluated on a continuous basis.
If you share our passion to improve the life of patients and residents with reduced mobility and wellness challenges, then we look forward to receiving your application.
Thank you for your interest and we hope you will join us on our exciting journey!
About us
Arjo is a globally minded company with a Swedish heritage, where a thriving international environment is driven by Swedish leadership culture. As a company that puts people at the heart of everything we do, Arjo employees are our partners in our mission to improve the quality of lives for people.
Publiceringsdatum2018-10-09Så ansöker duSista dag att ansöka är 2018-11-01
Klicka på denna länk för att göra din ansökanFöretagArjo AB Publ
AdressArjo AB Publ
Hans Michelsensgatan 10
21120 Malmö
KontorsadressHans Michelsensgatan 10
Jobbnummer 4392639
Observera att sista ansökningsdag har passerat.