Senior Quality Engineer.
Stryker is hiring a Senior Quality Engineer in Sandy Springs, GA! In this role, you will provide quality engineering support and direction in quality assurance, control, and preventative activities with a focus on continuous improvement of products and processes. Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers. Ensure compliance to regulation and standards. This role focuses on strengthening QA support to drive integration, remediation, and transfer efforts, with a long-term impact. You'll help mitigate risks and work closely with the team to ensure seamless operations!
What you will do:
- Responsible for working with integration team to complete assigned deliverables related to cleanroom activities.,
- Support manufacturing transfer by executing appropriate quality activities.
- Review and own assigned change management activities, including creating/updating procedure/work instructions.
- Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, take action as necessary.
- Responsible for initiation, internal containment, and support of ship and product holds for potential product escapes.
- Support execution and analysis of complaints and product field actions.
- As a NC/CAPA owner & activist, oversee problem-solving and root-causing activities while driving for resolution.
- Drive continuous improvement actions to reduce manufacturing defects & eliminate waste.
What you will need:
Required:
- Bachelor Degree in Engineering, Science or related field.
- 2+ years’ experience in a Quality Assurance role.
- Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics)
Preferred:
- Familiarity of ISO 13485, 21 CFR Part 820 Quality Systems, GDP, & GMP.
- Ability to represent Quality function with project teams.
- Ability to successfully manage and complete projects in a matrix organization.
- Strong analytical skills.