The Engineer I, Production Quality Engineering is responsible for understanding quality requirements, developing and improving processes to meet those requirements, driving internal efforts for root cause analysis and corrective actions, while providing day to day support of processes to meet our high standards of precision and quality in producing medical devices. Job Responsibilities and Essential Duties In this role you will be responsible for developing and maintaining quality engineer methodologies and providing quality engineering support to production:
- Identify and support implementation of effective process control systems for the development, qualifications, and ongoing manufacturing of products to meet, or exceed, internal and external requirements.
- Support in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
- Use problem-solving methodologies to resolve quality issues.
- Support process control and monitoring of CTQ parameters and specifications.
- Support implementation of various product and process improvement methodologies (E.G., Six Sigma and Lean Manufacturing).
- Systematically own product and process nonconformances which includes the investigation, resolution and prevention of future recurrence.
- Completion of historic NCR queries.
- Support in the completion and maintenance of risk analysis.
- Completion of Change Assessment Forms for ECO submissions.
- Ownership of the creation of PQE Management Review Slides.
Minimum Requirements
- Bachelor's Degree in Engineering or Science, or equivalent work experience is required.
- A minimum of one year of Quality Management Systems (QMS) is desired.
Required Knowledge, Skills, and Abilities
- Good analytical and problem-solving skills.
- High level of attention to detail and accuracy.
- Effective verbal and excellent technical writing skills.
- Ability to communicate and work effectively at multiple levels within the organization.
- Ability to plan, prioritize, organize, and coordinate multiple tasks and projects with discipline in a fast-paced environment
- Strong computer skills, including MS Office application (Word/Excel/Outlook/PowerPoint)
- Knowledge of Statistical software is desired.
- Knowledge of Quality Assurance methods, such as process validation, design of experiments, statistical process control (SPC) and protocol/report preparations is desired.
- Knowledge of ISO 13485 and FDA requirements is desired.
Supervision/Management Of Others:
Internal and External Contacts/Relationships
- Work closely with Operations, Manufacturing, Engineering, Maintenance, Quality Compliance, Design Quality, and Supplier Quality.
Environmental/Safety/Physical Work Conditions
- Ensures environmental consciousness and safe practices are exhibited in decisions
- Use of computer and telephone equipment and other related office accessories/devices to complete assignments
- Office or production environment
- May work extended hours during peak business cycles
Salary Range: $70K - 85K Depending on Experience
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Getinge
Dec 06, 2024