Job OverviewThe Sr. Engineer, Quality Operations 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 DutiesIn this role you will be responsible for developing and maintaining quality engineering methodologies and providing quality engineering support to production.
- Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
- Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving critical quality issues
- Lead process control and monitoring of CTQ parameters and specifications
- Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
- Lead the investigation, resolution and prevention of product and process non-conformances and related CAPAs
- Lead in the completion and maintenance of risk analysis
Minimum Requirements- Bachelor's Degree in Engineering or Science, or equivalent work experience.
- A minimum of 5-6 years of Quality Management Systems (QMS) experience.
Required Knowledge, Skills and Abilities- Good analytical and problem-solving skills.
- High level of attention to detail and accuracy.
- Strong computer skills, including MS Office applications and statistical software are required.
- Knowledge of Quality Assurance methods, such as process validation, design of experiments, statistical process control (SPC) and protocol/report preparation.
- Knowledge of ISO 13485 and FDA requirements
Supervision/Management Of Others:- Sr. Engineer, Quality Operations will help to mentor more junior engineers.
Internal and External Contacts/Relationships- Sr. Engineer, Quality Operations position works closely with Operations, Manufacturing Engineering, Maintenance, Quality Compliance, Supplier Quality, and Continuous Improvement.
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.
The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
$95K-120K with 10% STIP
#LI-YA2 #LI-Onsite
Benefits at Getinge:At Getinge, we offer a comprehensive benefits package, which includes:
- Health, Dental, and Vision insurance benefits
- 401k plan with company match
- Paid Time Off
- Wellness initiative & Health Assistance Resources
- Life Insurance
- Short and Long Term Disability Benefits
- Health and Dependent Care Flexible Spending Accounts
- Commuter Benefits
- Parental and Caregiver Leave
- Tuition Reimbursement
