Quality Assurance Engineer II

2 weeks ago

Minneapolis, Minnesota, United States LanceSoft Full time
Position Overview:
As a Quality Assurance Engineer II, you will play a pivotal role in ensuring the integrity and excellence of our products. Your expertise will contribute to the development and maintenance of quality standards that govern our manufacturing processes.

Key Qualifications:
- A minimum of 2 years of experience in product development.
- In-depth understanding of Risk Management principles.
- Strong communication skills and critical thinking abilities, particularly in root cause analysis.

Core Responsibilities:
Your day-to-day activities will include:
1. Regular updates and remediation of risk management documentation (such as FMEAs and PHAs).
2. Collaborating with manufacturing teams to address Non-Conformance Reports (NCRs), Corrective and Preventive Actions (CAPAs), and change assessments.
3. Evaluating complaint signals and determining appropriate next steps.

Product Support:
This role will likely support self-expanding stents, contributing to the advancement of our product line.

Work Environment:
This position offers a hybrid work model, requiring three days onsite, typically on Tuesdays and Thursdays, with the third day being either Monday or Wednesday.

Responsibilities Include:
- Developing, modifying, and maintaining quality standards and protocols for processing materials into finished products.
- Collaborating with engineering and manufacturing to ensure compliance with quality standards.
- Designing and implementing inspection and testing methods to evaluate product precision and accuracy.
- Conducting quality assurance tests and performing statistical analyses to identify non-compliance issues.
- Ensuring corrective actions meet reliability standards and documentation adheres to requirements.

Specialist Career Stream:
This role is primarily an individual contributor position, responsible for managing projects and collaborating with stakeholders to achieve desired outcomes. You may also mentor junior colleagues.

Autonomy and Impact:
As an established contributor, you will work independently on moderately complex projects, setting objectives that align with project goals and contributing to milestone achievements.

Innovation and Problem Solving:
You will face general problems that may require a broader understanding of various issues, making adjustments or recommending enhancements to improve processes.

Communication:
Your role will involve frequent communication with internal teams, sharing information and updates to support decision-making.

Leadership:
You may provide guidance to entry-level professionals and support staff in their career development.

Required Knowledge and Experience:
A University Degree and a minimum of 2 years of relevant experience are required, or an advanced degree with no prior experience.

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