Senior Design Quality Engineer

url to apply- https://www.timesjobs.com/job-detail/senior-design-quality-engineer-abbott-india-ltd-5-to-8-yrs-jobid-oJYUlG2CGBZzpSvf__PLUS__uAgZw==&source=srp

url to apply- 

Abbott India Ltd

• card_travel5 to 8 yrs
• ₹As per Industry Standards
• location_onUnited States of America (USA) (United States Of America (usa))

JOB DESCRIPTION

This job description will be reviewed periodically and is subject to change by management.


Abbott Rapid Diagnostics is part of Abbotts Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for the workplace, healthcare providers, and individuals.

RESPONSIBILITIES:
- Lead quality assurance support in the design and development/on market support of In-Vitro Diagnostics (IVD) medical device products, facilitating the application of design/change controls, risk management, quality planning and implementation of design and development plans
- Create and maintain risk management files such as UMFMEA/DFMEA/PFMEA that identify Hazard Analysis Critical Control Points (HACCP) and are compliant with the requirements of ISO 14971:2012
- Work closely with R&D, Manufacturing, Quality Control, and Applications Support management to prevent non-conformities and provide solutions to complex issues
- Lead and support multiple projects, balancing priorities and resources to meet project and management expectations
- Review and approve proposed changes for on market products by performing risk assessments, providing guidance and support and assessing the adequacy of verifications and validations and DMR documents
- Resolve QIs and CAPAs by performing investigations, conducting root cause analysis and developing and implementing plans to resolve
- Review and approve verification, validation and qualification documents
- Lead process improvement projects
- Act as SME for key subsystems such as Design Control, Risk Management, Design Verification, Design Validation, Process Validation etc.
- Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the companys policies and practices; build productive internal/external working relationships
- Carries out duties in compliance with established business policies


MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE:
- BS/BA in field of Science such as Chemistry, Microbiology, Biology, Biochemistry or Engineering, OR equivalent experience
- Direct work experience in IVD or medical device/biotech or within a regulated manufacturing environment
- 5 years or more of Quality Assurance engineering experience (EX: Design Controls, Change Control, Process Validation, AND/OR on market quality engineering support and risk management)
- 5 years or more of hands-on risk management experience in creating/maintaining risk management files such as UMFMEA/DFMEA/PFMEA, Plans, Reports, etc.
- Experience reviewing and approving Device Master Record (DMR) documents
- Hands-on Design Verification, Design Validation/Process Validation and Design History File (DHF) experience
- Knowledge of FDA QSRs, ISO 13485:2016 and ISO 14971:2012 standards, HACCP and GDP requirements
- Minimal travel if necessary

PREFERRED QUALIFICATIONS:
- Experience supporting new product development
- Hands-on experience with CAPA System, Non-conformity System, Root Cause investigation AND/OR manufacturing process improvement experience
- Knowledge of IVDR in EU and GLP requirements
- Process, QMS or Supplier auditing experience
- Experience with cleaning, mixing and test method validation
- Experience with reagent, ELISA, HEIA manufacturing
- Lean Six Sigma (Black or Green Belt), Certified Quality Engineer, Certified Quality Auditor

COMPETENCIES:
- Team player
- Interpersonal Skills
- Drives for results
- High level of attention to detail

• JOB FUNCTION:Production/Manufacturing/Maintenance/Packaging
• INDUSTRY:Healthcare, Manufacturing/Industrial
• SPECIALIZATION:QA/QC
• QUALIFICATION:
  • Any Graduate
• EMPLOYMENT TYPE:Full Time

KEY SKILLS

iso 13485lean six sigmaqahaccpchange controlvalidationquality controlquality auditorquality assurancepfmeaquality engineergreen beltquality engineeringcapaquality assurance engineeringprocess validationquality planning