Senior Quality Control Engineer

We are seeking a knowledgeable and detail-oriented Senior Quality Control Engineer to oversee quality control activities in support of NTx Scribe platform manufacturing and release. This role is critical in ensuring product sterility stability and compliance with regulatory and quality standards. The ideal candidate will bring expertise in sterility assurance stability program management and laboratory oversight with a strong understanding of FDA and ISO requirements for medical devices.

Your Responsibilities

• Lead quality control operations including incoming material inspection in-process testing and final product release for medical devices.
• Oversee sterility assurance processes including sterilization validation (EtO gamma) for devices from external partner.
• Manage product stability programs including protocol design study execution data trending and shelf-life determination per regulatory requirements.
• Develop and implement QC test methods procedures and specifications in compliance with ISO 13485 and FDA 21 CFR Part 820.
• Collaborate with cross-functional teams to resolve non-conformances conduct root cause investigations and implement corrective and preventative actions (CAPA).
• Support validation and qualification of laboratory equipment test methods and cleanroom environments used for manufacturing and testing of medical devices.
• Analyze and trend QC data to identify potential manufacturing issues and lead continuous improvement initiatives.
• Ensure compliance with applicable regulations and standards including ISO 14971 ISO 11135 ISO 11737 and ICH Q1A/ Q1E for stability testing.
• Train and mentor QC technicians and junior engineers on testing procedures protocols documentation practices and quality standards.
• Participate in internal and external audits and regulatory inspections as a subject matter expert for QC stability and sterility programs.

Who You Are

• Bachelors degree in Engineering Microbiology Chemistry or related field (Masters preferred).
• Minimum 57 years of experience in quality control within the medical device or pharmaceutical industry.
• Proven expertise in sterility assurance stability testing and GMP laboratory operations.
• Strong knowledge of FDA QSR ISO 13485 ISO 14971 and applicable ICH guidelines.
• Experience with quality control tools such as SPC control charts and trend analysis.
• Excellent documentation communication and organizational skills.
• Certifications such as CQA (Certified Quality Auditor) CMQ/OE or relevant microbiological/sterility credentials are a plus.

Working Conditions & Physical Requirements

• The working environment is generally favorable and comprises laboratories manufacturing clean rooms and office environments.
• Lighting temperature and noise levels are adequate.
• Personal Protective Equipment is required where stated. This includes a lab coat hair/beard net safety glasses gloves and safety shoes.
• While performing the duties of this job the employee is frequently required to sit stand and walk to the different lab areas.
• Frequent use of hands to manipulate handle or touch objects tools or controls.
• May be required to lift up to 20lbs.
• Specific vision abilities required by this job include vision color vision depth perception and the ability to adjust focus.
• Employees may be exposed to moving mechanical parts fumes or airborne particles and chemicals.

This position is in Rio Rancho NM.

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At Natures Toolbox we are a small team of great minds with an even larger vision. Join us today and contribute to change how life-saving therapeutics are manufactured today.

Natures Toolbox Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race color gender age religion national origin ancestry disability veteran status genetic information sexual orientation or any characteristic protected under applicable law.

NTx does not accept unsolicited resumes from any source other than directly from a candidate. Any unsolicited resumes sent to NTx including unsolicited resumes sent to a NTx mailing address email address directly to NTx employees or to NTxs resume database will be considered NTx property. NTx will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.NTx will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred to by the Agency free of any charges or fees.