Manager Quality Assurance/Quality Systems

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
People Leader

All Job Posting Locations:
Uppsala, Uppsala County, Sweden

Job Description:

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at https://www.jnj.com/

J&J MedTech is recruiting for a Manager Quality Assurance/Quality Systems reporting to the Quality Director and to be based in Uppsala (Sweden).

In Uppsala, we manufacture Healon, a market-leading product used to stabilize the eye in connection with eye surgery.

Upon its launch in 1980, Healon paved the way for safe and quick eye surgery, whereby a patient’s cataracts can be replaced with new lenses in just a few minutes.

JOB POSITION SUMMARY

Quality assurance of Product, Raw materials, Media and Manufacturing processes.

Process Owner for the Release Process, Document/Change control Process, Validation Process, Training Process and Labeling Process.

Operational planning, resource planning and KPIs are carried out within Uppsala Quality Assurance team.

Ensure that appropriate Quality Systems and Controls are in place for monitoring and detecting deviations in critical processes.

Ensure that responsibilities and authority and working methods within Uppsala site are regulated by written procedures that comply with applicable regulations.

Operate in accordance with applicable regulations and standards, as well as GMP requirements for the markets where AMO Uppsala's products are marketed.

Overall cost center responsibility for the Quality Assurance team.

This position is also operative within the Quality Assurance team responsibilities (70/30: Operative/Strategic position).

DUTIES & RESPONSIBILITIES

Duties for Manager QA/QS involve the following areas:


* Quality Management - Develop and improve quality management processes and ensure that quality management processes within AMO Uppsala meet Division / company requirements.


* Ensure that appropriate quality systems and controls are in place for monitoring ...