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Quality Assurance Inspector II
2 months ago
In the realm of Quality Assurance, the role involves assessing materials and products to ensure they meet specified requirements, procurement standards, and established protocols. This includes evaluations related to dimensions, functionality, aesthetics, and necessary documentation as outlined in the relevant inspection plan.
Key Responsibilities
- Conduct Quality Control inspections in accordance with established procedures.
- Interpret and analyze engineering drawings and associated Geometric Dimensioning & Tolerancing (GD&T).
- Perform mechanical, visual, and functional inspections.
- Create, complete, and maintain quality documentation including inspection records, non-conformance reports, deviations, and scrap forms.
- Manage non-conforming materials following prescribed procedures.
- Execute transactions in the ERP system as needed to release products from inspection.
- Adhere to all company policies and procedures.
- Conduct evaluations of documentation.
- Collaborate with various departments including Purchasing, Shipping, Receiving, Manufacturing, Engineering, and Supplier representatives.
- Support auditors during internal audits.
- Undertake additional responsibilities as assigned.
Qualifications
The qualifications outlined below represent the necessary knowledge, skills, and abilities required for this position. Reasonable accommodations may be provided to enable individuals with disabilities to perform essential functions.
- Effective communication skills, both verbal and written.
- Strong organizational skills and meticulous attention to detail.
- Basic proficiency in mathematics and computer skills.
- Comprehensive understanding of 21 CFR (Code of Federal Regulations), Part 820.
- Thorough knowledge of ASTM (Association of Systems & Test Methods) standards and Heat Treat conditions per ASTM standards.
- Experience in a controlled or regulated environment is essential.
- Familiarity with inspection tools such as Optical Comparators, Vision Systems, and hand tools.
Education and Experience
A High School Diploma or equivalent is required, along with 1-2 years of relevant experience; experience in the medical device industry is preferred.
Alphatec Spine is dedicated to providing equal employment opportunities to all employees and applicants, regardless of race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with applicable laws. Additionally, Alphatec Spine will make reasonable accommodations necessary to comply with disability discrimination laws.
Compensation
Alphatec Spine, Inc. adheres to state and federal wage and hour laws. Compensation is based on the candidate's qualifications, education, skill set, years of experience, and internal equity, with a salary range of $48,000 to $57,000 for full-time positions.
