About the role
This is a 12 month contract role with full Stryker benefits.
Provide Supplier quality engineering support and direction in quality assurance, control and preventative activities within operations and other business functions, with a focus on preventative measures and continuous improvement of products and processes. Advocate and lead the execution of initiatives & projects to enhance quality performance within the business. Ensure compliance to regulation and standards.
What you will do:
- Will work within the quality operations team, under minimal supervision, with responsibility for quality related activities, including, but not limited to the following:
- Work closely with operations and the business functions to ensure quality performance of product and processes.
- Oversight and approval of NC & CAPA, activist and mentor in problem solving and root causing activities.
- Lead and participate in the development and improvement of the manufacturing processes for existing and new products.
- Analysis and review of concession requests.
- Review and approval of change management activities.
- Maintain KPI for monitoring of process quality, perform analysis and interpret trends, take action as necessary.
- Support execution and analysis of QATs.
- Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.
- Proficient in risk management practices and tools, having high expertise in process risk. Develop and provide input for risk management by identifying opportunities and weaknesses.
- Proficiency in and makes continuous strides towards optimization of inspection methods and sampling. Support First Article Inspections.
- Proficiency in statistical methods and application.
- Participate and interface in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise.
- Assist in the development, responsible for review & approval of process and equipment validation/qualification.
- Support manufacturing transfers to other plants/facilities, leading quality activities.
- Responsible for initiation, management and support of Ship, Product Holds, potential product escapes.
- Coach and mentor others in quality topics and activities.
What you will need:
- Bachelor degree in Science, Engineering or equivalent/ related subject and 2 or more years of work experience in a quality discipline, or
- Masters of Science, Engineering or related subject with 0 years of experience
- Previous experience in a regulated environment desirable.
- CQE or equivalent course work / experience desirable
- Proficient in understanding of Med Device manufacturing processes desirable.
- Familiarity with ISO 13485, GDP, GMP desirable.
Aplyr's read
Stryker excels in medical technology, attracting professionals passionate about innovation in orthopedics, surgical, and neurotechnology solutions.
What's promising
- •Stryker's innovative products lead advancements in orthopedics and neurotechnology.
- •Global presence offers diverse career opportunities across multiple regions.
- •Strong focus on research and development fosters continuous innovation.
What to watch
- •High competition in the medical technology sector may impact market share.
- •Regulatory challenges can affect product launch timelines.
- •Complex organizational structure may slow decision-making processes.
Why Stryker
- •Stryker's commitment to innovation in medical technology sets it apart.
- •Diverse product range across orthopedics, surgical, and neurotechnology.
- •Strong emphasis on employee development through varied roles and internships.
Aplyr’s read is generated by AI from public sources. Was it useful?
About Stryker
Stryker is a global leader in medical technology, offering innovative products and services in orthopedics, medical and surgical, and neurotechnology and spine.
