
Quality Assurance Manager New Product Introduction
Welcome to Stryker β a leading medical technology company dedicated to improving healthcare worldwide. We are currently seeking a highly skilled and experienced Quality Assurance Manager for New Product Introduction to join our dynamic team. In this role, you will play a crucial part in ensuring the quality and safety of our newly developed products. We are looking for an individual who is passionate about quality, detail-oriented, and has a proven track record of success in the medical device industry. If you are ready for a challenging and rewarding career with a company that is committed to making a difference in the lives of patients, we encourage you to apply for this exciting opportunity.
- Develop and implement quality assurance strategies and procedures for new product introduction process.
- Conduct thorough quality checks and audits on newly developed products to ensure they meet industry standards and regulatory requirements.
- Collaborate with cross-functional teams including R&D, manufacturing, and regulatory affairs to ensure quality standards are met throughout the product development process.
- Create and maintain quality documentation, including risk assessments, validation protocols, and reports.
- Identify and address any quality issues or non-conformities in a timely and effective manner.
- Stay up-to-date with industry regulations and standards to ensure compliance.
- Train and mentor team members on quality assurance processes and procedures.
- Drive continuous improvement initiatives to enhance product quality and reduce costs.
- Participate in internal and external audits to ensure adherence to quality standards.
- Communicate quality assurance updates and progress to senior management and other stakeholders.
- Collaborate with suppliers to ensure quality of materials and components used in product development.
- Develop and maintain relationships with regulatory bodies to ensure compliance with all applicable regulations.
- Conduct root cause analysis and implement corrective and preventive actions as needed.
- Monitor and analyze quality data to identify trends and areas for improvement.
- Serve as a subject matter expert on quality assurance practices and procedures.
Bachelor's Degree In A Related Field Such As Engineering, Quality Assurance, Or Business.
Minimum Of 5 Years Experience In A Quality Assurance Role, Preferably In The Medical Device Industry.
Strong Knowledge Of Regulatory Requirements And Standards Such As Fda, Iso, And Mdd.
Proven Track Record Of Successfully Managing New Product Introductions And Ensuring Compliance With Quality Standards.
Excellent Communication And Leadership Skills, With The Ability To Collaborate With Cross-Functional Teams And Drive Continuous Improvement Initiatives.
Documentation
Change Management
Process Improvement
Project Management
Data Analysis
Quality Control
Root Cause Analysis
Product Testing
Team Leadership
Risk assessment
Regulatory compliance
Supplier management
Communication
Customer Service
Leadership
Time management
Interpersonal Skills
Critical thinking
Attention to detail
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Quality Assurance Manager New Product Introduction in Mahwah, NJ 07430, USA is $90,000 to $130,000 per year. However, this can vary depending on factors such as experience, qualifications, and the specific company or industry. It is important to research and compare salaries for similar positions in the area to get a better understanding of the market rate.
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Stryker Corp. is engaged in providing medical technology products and services. It operates through the following segments: Orthopaedics, MedSurg and Neurotechnology and Spine. The Orthopaedics segment provides reconstructive and trauma implant systems. The Medsurg segment deals with surgical instruments and equipment, endoscopy, patient handling, and reprocessed medical devices. The Neurotechnology and Spine segment pertains to spinal implants and neurovascular products.

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