Quality Assurance Inspector II
2 weeks ago
In the realm of Quality oversight, this role involves assessing materials and products to guarantee adherence to design specifications, procurement standards, and approved methodologies. The evaluations encompass dimensional, functional, aesthetic, and documentation aspects as dictated by the relevant inspection protocols.
Key Responsibilities
- Conduct Quality Control inspections in accordance with established ATEC protocols.
- Interpret and analyze engineering drawings and related GD&T (Geometric Dimension & Tolerances).
- Execute mechanical, visual, and functional inspections.
- Create, finalize, and maintain quality documentation including inspection records, non-conformance reports, deviations, and scrap documentation.
- Manage non-conforming materials following prescribed procedures.
- Perform necessary transactions in the ERP system to release products from inspection.
- Adhere to all company policies and procedures.
- Conduct evaluations of documentation.
- Collaborate with various departments such as Purchasing, Shipping, Receiving, Manufacturing, Engineering, and Supplier representatives.
- Support auditors during internal audit processes.
- Undertake additional duties as assigned.
Qualifications
The qualifications outlined below represent the 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 abilities and meticulous attention to detail.
- Basic proficiency in mathematics and computer usage.
- Solid understanding of 21 CFR (Code of Federal Regulations), Part 820.
- Thorough knowledge of ASTM (Association of Systems & Test Methods) standards and Heat Treat conditions as per ASTM guidelines.
- 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; prior experience in the medical device sector is preferred.
ATEC is dedicated to ensuring equal employment opportunities for all employees and applicants, without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status, in compliance with all applicable federal, state, or local laws. Furthermore, ATEC will provide reasonable accommodations necessary to comply with disability discrimination laws.
Compensation
Alphatec Spine, Inc. adheres to state and federal wage and hour regulations, with compensation contingent upon the candidate's qualifications, education, skill set, years of experience, and internal equity. The salary range is $48,000 to $57,000 for a full-time annual position.
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