Summary:
A reputable contract manufacturing firm based in Minneapolis, MN, is in search of a Senior Quality Engineer specialized in Production. This role involves cultivating a culture of Quality and Continuous Improvement throughout the organization by ensuring adherence to Quality System standards.
The company, known for its innovative approach to medical contract manufacturing and expertise in intricate materials transformation for essential components used in diagnostics, wearable technologies, and electronic devices, is specifically seeking candidates with the following qualifications:
- Author, manage, and execute manufacturing process characterizations and validations (OQ and PQ), explaining their purpose and differences while describing sampling rationale for each.
- Lead Process Failure Modes and Effects Analyses (PFMEA) generation, adhering to PFMEA requirements and ISO 14971 standards.
- Conduct CAPA Investigations, proficient in all phases, tools, and methods, with a track record of successful implementations.
- Apply statistical methods in Quality Engineering, including Statistical Process Control (SPC) and process capability analysis, ensuring risk-based approaches.
- Perform Test Method Validation and Measurement System Analysis (MSA), addressing GR&R failures and sustaining capability.
- Address non-normal variables data appropriately and apply Design of Experiments (DOE) when needed.
- Utilize statistical software (e.g., JMP, Minitab) for Quality Engineering tasks.
- Define Quality personally and demonstrate understanding of FDA 21CFR820 and ISO 13485 requirements in Quality Engineering.
- Develop and implement Quality Control Plans, with practical examples of implementation.
- Engage with production personnel to support and foster a culture of quality and compliance, resolving challenges and driving sustainable improvements.
- Navigate ambiguity and make tough decisions to ensure customer requirements are met, drawing from experience in difficult situations.
Qualifications:
- A bachelor's degree in a scientific, engineering, or technical field.
- A genuine interest and commitment to process improvement.
- 7+ years of experience, including at least 3 years at the senior level, in the medical device or related manufacturing industries, with direct experience relevant to the job responsibilities.
- Proficiency in statistical techniques, data management, investigation techniques, and technical writing.
- Six Sigma Green Belt (or higher) certification is highly desirable.
Benefits Offered:
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Employer-Paid Basic Life Insurance
- Supplemental Life Insurance
- Employer-Paid Short-Term Disability
- Long-Term Disability
- 401(k) Plan
- Paid Time Off
- Paid Holidays
