Digital Quality Systems Manager
Digital Quality Systems Manager
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Job Description
Work Schedule
First Shift (Days)Environmental Conditions
OfficeJob Description
Discover Impactful Work:
The Digital Quality Systems Manager is responsible for ensuring efficient operation support and continuous improvement of enterprise digital quality applications across the Laboratory Products Group (LPG).
This role plays an integral part in improving user experience by optimizing system performance streamlining processes and delivering comprehensive support and training. The Digital Quality Systems Manager will collaborate with business users IT teams and quality collaborators to drive adoption ensure compliance and improve the efficiency of digital quality tools.
A day in the Life:
The Manager Digital Quality Systems will:
- Coordinate digital QMS applications to ensure reliability efficiency and compliance.
- Monitor system performance and issue resolution working closely with IT and vendors to minimize disruptions.
- Identify and implement process improvements to improve system usability and operational efficiency.
- Lead cross-functional and multi-site initiatives by partnering with IT to develop modify improve and implement IT systems for the Quality and Regulatory Organization.
- Develop policies and procedures supporting IT Systems used by Quality and Regulatory.
- Build and deliver training content for IT Systems used by Quality and Regulatory.
- Analyze Quality and Compliance processes translate Quality and Regulatory requirements into IT systems improvements and initiatives.
- Ensure digital QMS applications remain current with applicable Regulatory requirements (e.g. US EU ICH GxP etc.).
Education
- A minimum of a bachelors degree (Biological Sciences Engineering or a related field of study); an advanced degree is a plus.
- 10 years of related experience in quality systems.
- Project Management certification (PMP CSM etc.) is a plus.
Experience
- Strong expertise and practical experience with Project Management concepts and processes; including both Waterfall and Agile Methodologies.
- Experience working in regulated environments with applicable regulations/standards to GSG business including 21CFR820 21CFR803 ISO 9001 ISO 13485 IVDR cGMPs FDA Guidelines USP and GxP.
- Detailed knowledge of medical device manufacturing processes and experience with risk management regulations and standards including FDA 21 CFR 820 MDSAP IVDR ISO 13485 and ISO 1497.
- Detailed knowledge of software validation best practices; especially those in a regulated environment.
- Proven ability in leading compliance projects harness the benefits of working with cross-functional teams and deliver on implementation strategies. Experience managing direct reports is a plus.
- Experience with PPI Six Sigma or Lean Methodologies is a plus.
Knowledge Skills Abilities
- Demonstrates strong critical thinking and analytical skills; self-motivated proactive and able to complete projects on time.
- Strong verbal and written communication skills; able to effectively communicate at multiple levels in the organization.
- Passionate about achieving goals and experienced in building inspiring and guiding successful teams.
- Ability to travel.
Required Experience:
Manager
Employment Type
Full-Time
