Getinge · 4 hours ago
Sr. Engineer, Quality Operations
Merrimack, NH
Full-time
Onsite
Mid, Senior Level
$95K/yr - $120K/yr
5+ years expGetinge is a company dedicated to making life-saving technology accessible for more people. The Sr. Engineer, Quality Operations is responsible for understanding quality requirements and developing processes to meet those requirements while providing support to ensure high standards of precision and quality in producing medical devices.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
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
Qualification
Required
Bachelor's Degree in Engineering or Science, or equivalent work experience
A minimum of 5-6 years of Quality Management Systems (QMS) experience
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
Benefits
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
Company
Getinge
Getinge identifies customer issues and promotes clinical and economic benefits and follow and support the customer decision process.
10001+ employees
H1B Sponsorship
Getinge has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (3)
2023 (2)
2022 (2)
2021 (2)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
$539.31M2017-10-19Post Ipo Equity· $539.31M
2002-06-28IPO
Leadership Team
C
Christoffer Å.
Chief Information Security Officer
Joanna Engelke
EVP Quality Compliance, Regulatory, Medical
Recent News
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