Product Quality Assurance Manager
Share
Job Location:
Monthly Salary:
Posted on:
Vacancies:
Job Summary
JOB DESCRIPTION:
Abbott
At Abbott diverse ideas perspectives and expertise allow us to create the life-changing solutions that help people live healthier 196 countries and with businesses spanning nutrition diagnostics medical devices and branded generic pharmaceuticals Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals.
The Opportunity
Abbott Rapid Diagnostics (formerly Alere) is part of Abbotts Diagnostics family of businesses bringing together exceptional teams of experts and industry leading technologies. Our in-vitroDiagnostic Assay manufacturing site in Dundee has an exciting opportunity for a Product Quality Assurance Manager to join the Dundee Operations department. This is a 1st line leadership role.
What Youll Do
As the Product Quality Assurance Manager you will:
- Provide strategic oversight of:
- Independent approval of raw materials intermediates and finished products via Quality Record Audits and physical inspections.
- Product design process and facility changes through the Design Quality Group.
- Complaint intake reportability assessment investigation and resolution via the Product Support Team.
- Nonconformance and CAPA processes.
- Supplier Quality Assurance activities.
- Act as Depute Person Responsible for Regulatory Compliance (PRRC) ensuring final release of finished IVDs.
- Lead external audit and inspection programs.
- Represent QA in Tier 4 & 5 Management Operating System reviews and team briefings.
- Drive continuous improvement initiatives across cost quality and delivery metrics.
- Recruit develop and manage a high-performing QA team.
- Conduct monthly and annual performance reviews.
- Foster a culture of accountability ownership and excellence.
- Promote clear expectations and career development for Production Scientists.
Required Qualifications / Profile
- Degree level or equivalent preferably a life science subject area
- Experience in similarly regulated industry preferred
- Demonstrable leadership and management capabilities
- A practical understanding of record audit and material approval processes per ISO 13485:2016 for the Design and Manufacture of In-vitro Diagnostics
- A comprehensive technical understanding of the function and performance characteristics of the products and materials produced within the Operations environment.
- An ability to employ state-of-the-art Root Cause Analysis (RCA) tools including A3/DMAIC.
- The capability to contribute to and perform Risk Assessments Risk Management/Control exercises and Failure Mode Effect Analyses (FMEA).
- Experience with an Enterprise Resource Planning System (ERP)
- Experience with Electronic Document Management Systems (EDMS)
- Proficient with MS Word Excel and Power-Point.
As youd expect from an innovative global health care company we offera competitive range of benefits including excellent salaries a class-leading defined contribution pension scheme private healthcare life assurance and a flexible benefits scheme.
Abbott is about the power of health. For more than 135 years Abbott has been helping people reach their potential because better health allows people and communities to achieve us you can shape your career as you shape the future of healthcare.
With a diverse global network serving customers in more than 160 countries we create new solutions across the spectrum of health around the world for all stages of life. Whether its next-generation diagnostics life-changing devices science-based nutrition or novel reformulations we are advancing some of the most innovative and revolutionary technologies in healthcare helping people live their best lives through better health.
The base pay for this position is
N/AIn specific locations the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
CMI ARDx Cardiometabolic and Informatics
LOCATION:
United Kingdom > Dundee : 17 Luna Place
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
No
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
Required Experience:
Manager
Key Skills
- Quality Assurance
- FDA Regulations
- Food Industry
- Food Safety Experience
- ISO 9001
- Quality Systems
- Food Processing
- Quality Control
- Quality Management
- QA/QC
- Selenium
- HACCP
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
