QA officer Medical Devices

We are hiring!!! QA Officer Medical Devices

Ready to shape global health Join our Quality Team!!

Are you passionate about making a difference in global health Do you possess excellent technical skills, good communication abilities in English, are passionate for supplier visit and have a keen eye for medical devices If so, then join us at Missionpharma, where you will be a key player in our dynamic quality team.

As QA Officer Medical Devices you will join a team of highly skilled colleagues. You will be working closely with colleagues across all locations (Kandla, Denmark, China). You will be based in Mifamed Medical Pvt Ltd., which is a fully integrated support office in the Missionpharma Group.

You will be responsible to:

Undertake the necessary discussions and explanations with the manufacturer with reference to medical device product query.

Collect and assess product and plant documentation and samples needed for product approval included but not limited to product questionnaire, product specifications, release criteria, stability studies.

Assist in review of medical device with reference to layout approval and COA review.

Assist in continuous improvement of quality management system to ensure better harmonization of pre-qualification status, regulatory activities, and procurement activities.

Perform desktop evaluations of product and plants as applicable.

Verification of ISO/CE and other certificates for its authenticity with certificate issuing body.

Cross department coordination for claims, deviations, root cause, product review & retesting.

Cross departmental coordination with Denmark quality team, purchase, sales in any issue related to products, client/ manufacturer on quotations.

Ensure a constructive dialogue with medical device manufacturers related to product range, ISO 13485/MDR compliance and product file level.

To visit medical device supplier for quality assessment of product and site

Professional competences required:

Master/bachelor's degree in Pharmaceutical/Engineering (Biomedical) or equivalent (upto 6 Years experience.)

On hands experience with ISO 13485 standards, EU MDR standards, CE guide to handle the product related issues.

Good knowledge of national and international, quality management systems.

Excellent verbal and written technical communication skills in English.

Well structured, detail oriented, efficient with ability to follow up and communicate results.

• Should be able to review documents such as stability studies, manufacturing processes and product specifications, certificate verification.
• Should be able to enter a dialogue with the manufacturer for product specific evaluation.
• Ability to use current job-related computer software and databases with proficiency in Microsoft Office package, in particular Word, Excel, and PowerPoint, is required.
• Should be self-dependent of character and able to put forward any issues needed in order to ensure a sufficient product quality.
• Ability to establish harmonious work relationship with all colleagues in an international and multicultural environment.

Personal competences required:

Structured

Good with planning and prioritization of tasks.

Confident behavior

Good team player

Positive attitude, sincere

Accountable

Excellent English communication skills.

About Missionpharma:

Missionpharma is one of the biggest suppliers of generic pharmaceuticals, medical devices, hospital equipment, and medical kits to African Ministries of Health, international donors, large NGOs, and the UN. Headquartered in Lynge, Denmark, we are a global organisation with over 150 employees representing 15 nationalities and with offices in India and China. We are powered by strong values and a commitment to making a difference. We believe that our purpose and our values tie us together as a company and drive us to keep aiming for making an impact. Together, we are on a mission for better health.

Join our mission-driven team and contribute to global health!

Why join us

A company that's impactful yet fosters personal development and growth opportunities.

Become part of multicultural global team with 15 nationalities, working together towards a common goal.

Contribute to global health impact through your role in Quality Assurance.

Room for technical growth and personal development in a supportive team environment.

Work in a diverse, inclusive, and culturally rich setting, emphasizing work life balance and collaboration.

How to apply

Apply by clicking on the link below not later than 12^th May 2024

https://candidate.hr-manager.net/ApplicationForm/SinglePageApplicationForm.aspxcid=1276&departmentId=18959&ProjectId=143641

We look forward to hearing from you!

Apply now!

#Ahmedabadjob#QualityAssurance#5daywork#medicaldevicespecialist#EUMDR#ISO13485#CEMarkcondition#EUMDD-EUMDRtransition#510kPMA#GHTFguidelines#dossierreview#IVDs #qualitymanagementsystem#riskassessment#plantassessment#goodcommunication