Lead Quality Engineer, Production and Process Controls, Digital
Lead Quality Engineer, Production and Process Controls, Digital
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$ 93280 - 139920
1 Vacancy
Job Description
Job Description Summary
This position will support the Chicago Quality Organization by supporting digital manufacturing and distribution controls. You will work with cross functional teams to provide guidance and ensure compliance with QMS requirement activities to ensure patient safety reduce regulatory risk and enable commercial delivery of GE HealthCare Digital products.GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition turn ideas into worldchanging realities and join an organization where every voice makes a difference and every difference builds a healthier world.
Job Description
Roles and Responsibilities
Foster a Quality culture by driving compliance to global and local policies procedures and work instructions included in the Chicago Site Quality Plan
Support the Chicago Manufacturing Site by implementing and overseeing robust production and process controls
Collaborate with cross functional stakeholders to aid continuous improvement (lean) projects
Conducts internal audits of the QMS to ensure high level of compliance
Supports external audits from regulators by preparing information assisting during the audit execution and follow up of post audit activities
Performs a broad variety of QMS & compliance tasks as result of continual improvement initiatives or as assigned by supervisor
Champions the evolution of the quality culture which includes executing and driving quality objectives metrics reporting and operating mechanisms for QMS processes
Support the Chicago Quality team by following up on production and process controls related project deliverables
Explains information and influences team members to consensus around total quality and continuous improvement.
Employs risk based thinking approach across QMS processes.
Required Qualifications
Bachelors degree from an accredited university or college (or a high school diploma / GED with at least 4 years of experience) in computer science or engineering field.
Minimum of 2 years of work experience in quality assurance or quality engineering in a regulated industry.
- Legal authorization to work in the U.S. is required. Sponsorship for employment visas now or in the future for this job opening is not available.
Desired Characteristics
- Good understanding and knowledge of local and global Medical Device QMS regulations and standards such as but not limited to FDA 21 CFR 820 EN ISO 13485 EU MDR.
- Experience with Software as Medical Device (SaMD) and Medical Device Manufacturing (GMP) is a plus.
- Demonstrated expertise to effectively communicate within all levels of an organization around concepts like NC Corrective & Preventive Action (CAPA) Personnel training Document & Record control and product quality.
- Knowledge of Risk Management standards/practices.
- Strong oral and written communication skills.
- Demonstrated ability to analyze and resolve problems.
- Strong time management prioritization and organization skills.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus and drive ownership always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into worldchanging realities. Our salary and benefits are everything youd expect from an organization with global strength and scale and youll be surrounded by career opportunities in a culture that fosters care collaboration and support.
For U.S. based positions only the pay range for this position is $93280.00$139920.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills qualifications experience and location. In addition this position may also be eligible to earn performance based incentive compensation which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package including not but limited to medical dental vision paid time off a 401(k) plan with employee and company contribution opportunities life disability and accident insurance and tuition reimbursement.Additional Information
GE HealthCare offers a great work environment professional development challenging careers and competitive compensation. GE HealthCare is anEqual Opportunity Employer. Employment decisions are made without regard to race color religion national or ethnic origin sex sexual orientation gender identity or expression age disability protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID19 some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: No
Employment Type
Full-Time
