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Quality Assurance Engineer
2 months ago
Job Overview
As a key player in our quality assurance initiatives, you will be responsible for overseeing the technical aspects of our quality control program, ensuring that our products consistently meet established standards.
Key Responsibilities
Your role will involve monitoring and analyzing statistical data and product specifications to assess the compliance of incoming raw materials, subassemblies, and finished products with company requirements and industry standards.
You will manage multiple projects from the initial product concept through development, manufacturing, and customer usage.
Specific Duties Include:
- Generating, updating, and reviewing process documentation for release through the change order process, ensuring inspection procedures are current.
- Leading and participating in problem-solving initiatives related to design, manufacturing, and inspection/testing, including CAPA, NCR, and supplier issues.
- Conducting IQ/OQ and PQ activities, selecting test sample sizes, validating test methods, and performing Gage R&R studies to ensure compliance with product quality standards and regulations.
- Monitoring and managing the Non-Conformance process and participating in MRB activities.
- Organizing and maintaining Quality Control Records and ensuring the availability, maintenance, and calibration of inspection equipment.
- Supporting internal and external audits, formulating responses to audit findings and CAPAs.
- Preparing and reporting QC metrics during QMS reviews.
- Assisting with the maintenance and calibration coordination program and related activities.
- Performing additional duties and special projects as assigned.
Qualifications
Minimum Requirements:
- A minimum of two years of experience in quality control processes for the inspection and testing of electronic components, subassemblies, and finished products, or equivalent experience.
- Practical experience in implementing and utilizing statistical methods throughout various stages of product realization, such as PFMEA, DFMEA, DOE, and GR&R methodologies.
- Familiarity with Quality Management Systems (QMS) in regulated industries and knowledge of equipment calibration processes and regulatory requirements.
- Proficient in Microsoft Office Suite with excellent written and verbal communication skills.
- Strong interpersonal skills for effective collaboration with peers and other departments.
- Ability to travel locally, domestically, and internationally as required.
- Capability to work independently with minimal supervision.
Preferred Qualifications:
- Experience in a Medical Device manufacturing environment.
- Knowledge of IPC 610, 620, IPC J-STD-001E, and MIL-T-31000/MIL-STD-100E standards.
- Familiarity with Part 820 Quality Systems Regulation and ISO-13485 requirements.
- Proficient in using Minitab for statistical data analysis.
Education:
A Bachelor's degree in engineering, manufacturing, or quality is required.
Compensation:
The anticipated salary range for this position is $61,000 - $91,000, with actual placement depending on various factors, including skills, education, and experience.
Work Environment:
This position primarily operates in an office, laboratory, and manufacturing setting, requiring frequent sitting, standing, and walking. Daily use of computers and other digital/mechanical devices is essential. The role may involve lifting up to 35 pounds regularly and may require local, domestic, and international travel up to 20% of the time.
Reasonable accommodations may be made to enable individuals with disabilities to perform essential job functions.