Principal Quality Engineer
2 weeks ago
Stryker Group LLC is seeking a Senior Quality Assurance Engineer to join our team. In this pivotal role, you will work alongside various internal teams to enhance product quality, pinpoint opportunities for continuous improvement, and deliver technical and compliance support.
Who we are looking for:
Committed achievers:
Individuals who excel in a dynamic environment and are dedicated to ensuring projects are completed while adhering to regulations and expectations.
Collaborative team players:Professionals who foster and utilize cross-functional relationships to integrate ideas, information, use cases, and industry insights to establish best practices.
Skilled communicators:Experts who can clearly and accurately interpret information to effectively communicate results and recommendations to stakeholders, senior management, and their teams.
Key Responsibilities:
- Establish and nurture relationships with various divisions and business units that the manufacturing facility serves.
- Drive initiatives for continuous improvement within the Quality Assurance domain, including opportunities for cost reduction. Previous experience with Lean methodologies is advantageous.
- Champion and oversee the execution of projects aimed at enhancing quality performance and ensuring compliance with regulations and standards.
- Collaborate closely with operations and business functions to guarantee the quality performance of products and processes.
- Provide guidance and approval for Non-Conformance (NC) and Corrective and Preventive Actions (CAPA), mentoring teams in problem-solving and root cause analysis.
- Support the development of junior engineers through coaching and mentorship.
- Work in partnership with operations and strategic partners, such as Manufacturing, Engineering, and Supply Planning, to achieve strategic goals.
- Engage in internal and external audits with regulatory representatives, delivering effective narratives and descriptions of your areas of expertise.
- Ensure that regulatory requirements are integrated into projects and processes.
- Utilize statistical methods to validate the reliability of manufacturing processes.
- Assist in the development and oversee the review and approval of process and equipment validation/qualification.
- Manage and support product holds and potential product escapes.
- Identify opportunities and weaknesses to contribute to risk management efforts.
- Demonstrate proficiency in optimizing inspection methods and sampling processes.
Qualifications:
Required:
- Bachelor's degree in Engineering - Biomedical, Mechanical, or a related field.
- A minimum of 6 years of relevant experience.
- Experience in a regulated industry is essential.
- Qualification as an Internal Quality Auditor (ISO 13485, CFR 820, or comparable industry standards and regulatory requirements).
- Experience in a highly regulated environment is desirable.
- Familiarity with PFMEA, validation programs, and Statistical Process Control (SPC) processes.
- Understanding of manufacturing prints and tolerancing.
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