Overview
QC Supervisor/Manager Jobs in Waltham, MA at Repligen Corporation
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Job description
We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more:US Stryker employee benefits.
Stryker is hiring a Quality Engineer to support our Neurovascular team in Salt Lake City, Utah! In this role, you will promote quality and lean practices, identify and resolve issues, and communicate effectively across all levels of the organization to drive results and deliver high-quality products to our patients and customers.
What you’ll do:
You will be part of the Quality Operations team, supporting a range of quality-related activities, including but not limited to the following:
Lead and manage Nonconformances (NC) and Corrective and Preventive Actions (CAPA), with a focus on root cause analysis and problem-solving.
Support development and continuous improvement of manufacturing processes for both existing and new products.
Contribute to change management activities and support execution and analysis of Quality Acceptance Tests (QATs).
Monitor and analyze KPIs related to process and supplier quality to identify trends and drive corrective actions.
Promote Human Factors practices, including identification, reduction, and mitigation strategies.
Develop proficiency in risk management, statistical methods, and process risk assessment to support quality initiatives.
Support optimization of inspection methods and sampling strategies, including First Article Inspections.
Interpret manufacturing prints and tolerances.
Foster strong relationships and support team and stakeholder outcomes through open communication, collaboration, and effective interpersonal skills.
What you need:
Required:
Bachelor of Science in Engineering or related discipline
0+ years of related experience
Preferred:
Experience in Medical Device or Pharmaceutical
Internship or hands-on experience in quality engineering, quality assurance or manufacturing within a regulated industry
Solid understanding of engineering and quality concepts/theories
Familiarity with ISO 13485, Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP)
Knowledge of Risk Based and statistical concepts
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
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Title: QC Supervisor/Manager
Company: Repligen Corporation
Location: Waltham, MA
