Engineering Journal Jobs in Boerne, TX

Job Title: Director of Quality Assurance – Tissue Processing

Location: San Antonio, Texas, USA

Department: Quality Assurance / Regulatory Affairs

Reports To: Executive Leadership

FLSA Status: Exempt

Position Summary

The Director of Quality Assurance is responsible for providing strategic leadership, direction, and oversight to the company’s Quality Management System (QMS) to ensure compliance with international and domestic tissue processing regulations, standards, and corporate policies. This role establishes quality strategy, directs organizational compliance programs, and ensures alignment with corporate objectives across all quality assurance processes, including regulatory compliance, internal and external audits, risk management, supplier quality, and continuous improvement initiatives. The Director of Quality Assurance serves as a key member of the leadership team, providing executive-level guidance on quality strategy and regulatory risk management, ensuring the delivery of safe and effective products that meet or exceed customer and regulatory requirements.

Essential Duties and Responsibilities

• Lead the implementation, maintenance, and improvement of the QMS in compliance with cGMPs, ISO 13485:2016, ISO 14971:2019, and FDA 21 CFR:

Part 11 (Electronic Records; Electronic Signatures), 

Part 820 (QSR)

Parts 361/1271 (Human Cells, Tissues, and Cellular and Tissue-Based Products)

And the relevant FDA Guidance documents for these regulations

• Provide oversight of product release strategy and ensure compliance through delegated authority.
• Establish and oversee policies for raw material acceptance, supplier controls, and product disposition.
• Ensure organizational compliance with labeling and packaging requirements through policy, audit, and review.
• Plan, manage, and resource internal audits, supplier audits, and regulatory inspections; serve as the host and primary point of contact for regulatory and notified body representatives.
• Assure programs related to document control, GMP training program, and controlled record management are in compliance.
• Direct Quality approval for the CAPA process, including nonconformance handling, root cause analysis, corrective/preventive action planning, and effectiveness verification.
• Provide oversight and guidance for product risk management in accordance with ISO 14971.  Perform the quality review function for device pFMEA/dFMEAs and design control through delegation to appropriately trained and qualified staff.
• Review and approve quality-related documentation, including validation protocols, verification reports, design control deliverables, and batch records.
• Develop the key quality metrics for the periodic QMSR (Quality Management Systems Review) to drive systemic improvements, enhancing compliance and operational effectiveness.  
• Develop, mentor, and direct the Quality team and oversee staff development across multiple quality functions to ensure alignment with company goals and regulatory expectations.
• Partner with cross-functional teams (Process Engineering, Manufacturing, Warehouse/Distribution, Regulatory Affairs, Operations, Sales) to support quality throughout the product lifecycle.
• Competency and proficiency in making standard Regulatory submissions, updates, and communications, such as FDA Establishment Registrations, 510k’s, State Registrations, and FSCA for Medical Devices. 
• Ability to guide the organization to compliantly launch new medical device products and configurations to market

Required Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Quality, or related field; advanced degree strongly preferred.
•  Minimum of 10–12 years of progressive experience in tissue processing quality assurance, with at least 5+ years in a director-level or equivalent leadership capacity.
• Comprehensive knowledge of ISO 13485, FDA 21 CFR Part 820, ISO 14971, and EU MDR.
• Demonstrated experience and favorable outcomes with FDA inspections, notified body audits, and supplier quality programs.
• Expertise in QMS software platforms and document control systems.
• Strong analytical, problem-solving, and decision-making skills. 
• Professional certifications CQA, CQE, LSSBB, or RAC.

Competencies

• Executive leadership and organizational management skills
• Regulatory compliance expertise
• Effective communication and presentation abilities, including executive reporting and Board-level communication
• Strong attention to detail
• Continuous improvement mindset
• Demonstrated ability to mentor and coach staff and peers

Work Environment & Physical Requirements

• This position operates in a professional office and/or manufacturing environment.
• Regular use of computers, phones, and office equipment.
• May require occasional lifting of materials up to 25 pounds.
• Exposure to manufacturing floor environments.

Travel Requirements

• Occasional domestic travel may be required (estimated 20%) to support audits, supplier evaluations, and regulatory inspections.

Compensation & Benefits

• Competitive base salary commensurate with experience.
• Performance-based annual bonus eligibility.
• Comprehensive benefits package, including medical, dental, vision, life insurance, and 401(k) with company match.
• Paid time off, sick leave, and company holidays.
• Professional development opportunities and continuing education support.

Job Title : Nuclear Engineer (Naval Reactors Engineer) Category / Component : Officer • Active Overview Design, regulate, and oversee the Navy's nuclear propulsion program, including reactor design, fleet operations, and eventual defueling and decommissioning of nuclear powered ships and submarines from Naval Reactors Headquarters and associated Department of Energy laboratories and shipyards.

Key Responsibilities Provide technical direction in areas such as reactor and fluid systems design, reactor physics, materials development, component design for steam generators, pumps, and valves, instrumentation and control for reactor and propulsion plants, testing and quality control, radiation shielding, and chemistry and radiological controls; review designs and analyses from laboratories, shipyards, and industry partners; coordinate with fleet units to ensure safe and reliable nuclear plant operation.

What to Expect Assume significant technical responsibility early in your career as part of a lean headquarters staff; work primarily in an analytical and oversight role rather than operating plants at sea; balance long term engineering projects with time sensitive fleet and shipyard issues; frequent coordination with senior civilian engineers, naval officers, and technical teams; high expectations for attention to detail, judgment, and written and oral communication.

Work Environment Work mainly at Naval Reactors Headquarters in the Washington, District of Columbia area with regular engagement with Department of Energy laboratories, nuclear training sites, shipyards, and nuclear powered ships and submarines; office based work that includes document reviews, technical meetings, inspections, and site visits rather than day to day shipboard watchstanding.

Pathways, Training & Advancement Officer commissioning through programs such as Officer Candidate School or the Nuclear Propulsion Officer Candidate program followed by a structured technical qualification program at Naval Reactors; rotational exposure to laboratories, prototypes, shipyards, and fleet support issues; progressive responsibility leading projects and becoming a subject matter expert, with opportunities for professional military education and advanced graduate study in technical fields.

Entry through the Nuclear Propulsion Officer Candidate program for qualified college students and recent graduates, or selection via Officer Candidate School for those who already hold qualifying degrees; all applicants must meet Nuclear Propulsion Program academic and technical screening standards in addition to general officer commissioning requirements.

Qualifications All Navy jobs require meeting general enlistment or commissioning standards, which typically include: Eligibility to serve in the United States Navy, which may involve United States citizenship or other legal residency and work status, depending on the program and current law and policy A high school diploma or equivalent for enlisted positions, and a bachelor's or qualifying professional degree for officer positions Meeting age limits that vary by program and are set in law and Navy policy.

Some communities have more restrictive age ranges Meeting medical, vision, and dental standards, including body composition and physical fitness requirements, with some jobs requiring more demanding standards Meeting character and conduct standards, including background screening Achieving required test scores for your program, such as the Armed Services Vocational Aptitude Battery for enlisted roles or officer qualification tests for officer programs Eligibility for a security clearance when required for your rating or designator Additional qualifications can include specific skills, education, licensure, or experience that are unique to a job or community and will be reviewed with you by a recruiter.

Additional qualifications for this job may include: Completion of a rigorous technical degree in engineering, physics, mathematics, or a closely related field that includes strong backgrounds in calculus and physics; outstanding academic record, particularly in technical coursework; United States citizenship and eligibility for a high level security clearance; strong technical aptitude and comfort with detailed analytical work.

Education Education benefits are available through standard Navy programs such as Tuition Assistance, the Post-9/11 GI Bill, ACE-recommended college credit for Navy training, Navy COOL-funded certifications, USMAP apprenticeships, and other Navy College Program opportunities.

Specific options depend on the Sailor's status, training, and current Navy policy.

Pay, Benefits & Service Pay, benefits, and service commitments follow standard Navy Active and/or Reserve policies for this type of role, including basic pay, allowances when eligible, health coverage, and retirement options.

Exact entitlements, special pays, and service obligations depend on program, component, years of service, and current law and Navy guidance.

Incentives Incentives such as bonuses, special pays, and loan repayment may be available at times for specific ratings or communities, but they change frequently and cannot be guaranteed.

Applicants must confirm current incentives and eligibility with an official Navy recruiter or authoritative Navy source.

Notes and Disclaimers This description is a general overview of typical duties, training, and opportunities in this community.

It does not replace official Navy instructions, policies, or contracts and does not guarantee specific assignments, training, incentives, or outcomes.

Actual opportunities depend on Navy needs, individual performance, screening results, and current law and policy.

About RevoGen Biologics LLC

RevoGen Biologics is committed to making lives better through cutting-edge biologics. Following time-tested rigorous guidelines, delivering quality products and services to our clients is our number one goal. We created RevoGen® Biologics with a client-centric mission in mind. Built on a solid foundation of best-practices and trust-driven relationships, we aim to improve the lives of everyone who uses our products. From doctors and surgeons to patients and distributors, we strive to deliver the most optimal experience for every person who interacts with RevoGen Biologics. Following rigorous, time-tested guidelines and conducting stringent donor screenings, we’re revolutionizing the field of bioregeneration to offer physicians and their patients quality biologics. 

Job Title: Tissue Bank Director

Location: San Antonio, Texas, USA

Department: Medical Affairs

Reports To: Medical Director

FLSA Status: Exempt

Position Summary

The Tissue Bank Director serves as the clinical expert for donor suitability, tissue recovery, processing criteria, supply requirements, quality metrics, and tissue training for the organization. The Tissue Bank Director provides leadership and oversight for all ocular, wound care, and bone filler tissue banking operations, including the recovery, processing, preservation, storage, and distribution of human ocular tissues and skin/amniotic or bone filler grafts used in transplantation, ophthalmic surgery, and advanced wound care. The Tissue Bank Director is responsible for creating an annual budget, forecasting tissue projections and revenue, and maintaining fiscal accountability within the department. In addition, the Tissue Bank Director is responsible for negotiating, executing, and adhering to processor and supplier agreements, including defined monthly, quarterly, and annual tissue allocation caps. The Tissue Bank Director is accountable for the tissue recovery staff’s adherence to all regulatory and accrediting agency standards, including, but not limited to CMS, FDA, and AATB, as well as all internal organizational policies, procedures, and guidelines. The Tissue Bank Director is responsible for strategic planning as it relates to departmental, tissue program, and donor network growth, and investigating business opportunities that lead to an increase in tissue donation and/or improvement in clinical outcomes.

 The Director ensures compliance with applicable regulations, including FDA 21 CFR Part 1271, AATB Standards, EBAA Standards, and state tissue banking requirements.

This role oversees supplier relationships, donor screening, validation, labeling, and release to maintain the highest standards of safety, sterility assurance, and ethical integrity.

Essential Duties and Responsibilities

·     Provide strategic leadership for ocular and wound graft tissue bank operations, including donor recovery, processing, packaging, labeling, and distribution.

·     Ensure full compliance with FDA 21 CFR 1271, AATB, and EBAA accreditation standards.

·     Develop, implement, and maintain Quality Management Systems (QMS) consistent with cGMP, cGTP, and ISO 13485.

·     Oversee donor eligibility determinations, donor records, and traceability of grafts.

·     Ensure sterile technique, aseptic processing, and validated preservation procedures for ocular and wound grafts (e.g., amniotic membrane, dermal tissue).

·     Manage staff training, competency assessments, and annual evaluations in compliance with AATB/EBAA standards.

·     Coordinate audits, inspections, and accreditation site visits; ensure timely response and corrective actions.

·     Review and approve all SOPs, validation studies, and change controls related to tissue processing and distribution.

·     Monitor product release, labeling, and final distribution for compliance with regulatory and internal quality standards.

·     Implement systems for product recall, deviation investigation, and complaint management.

·     Ensure donor and recipient adverse event tracking and regulatory reporting as required.

·     Foster collaboration with clinical partners, surgeons, and hospitals to ensure tissue quality and availability.

·     Lead initiatives in process improvement, cryopreservation, and innovative wound care product development.

·     Oversee documentation practices aligned with ALCOA+ data integrity principles.

·     Promote a culture of compliance, safety, and continuous improvement throughout all tissue bank operations.

Required Qualifications

·     Bachelor’s degree in Life Sciences, Biomedical Engineering, or related field required.

·     Advanced degree (MS, MPH, MBA, or PhD) preferred; CTBS certification strongly encouraged.

·     Certified Tissue Bank Specialist (CTBS) certification preferred.

·     Demonstrated experience and favorable outcomes with FDA inspections, notified body audits, and supplier quality programs.

• Expertise in QMS software platforms and document control systems.
• Strong analytical, problem-solving, and decision-making skills.

Competencies

·     Strong understanding of ocular tissue recovery, amniotic membrane processing, and aseptic wound graft techniques.

·     Proven ability to lead regulatory inspections and maintain accreditation.

·     Excellent leadership, communication, and analytical skills.

·     Proficiency in Quality Management Systems (QMS), document control, and risk management principles.

·     Ability to interface effectively with surgeons, clinicians, and regulatory professionals.

Work Environment & Physical Requirements

• This role operates within a combination of office, laboratory, and controlled cleanroom environments.
• Regular use of computers, phones, and office equipment.
• May require occasional lifting of materials up to 25 pounds.
• Exposure to manufacturing floor environments.
• May require standing for extended periods and occasional travel for audits or site visits.
• Compliance with biosafety and infection control protocols required.

Travel Requirements

• Occasional domestic travel may be required (approximately 10–20%) to support supplier evaluations and supplier business meetings.

Compensation & Benefits

• Competitive base salary commensurate with experience.
• Performance-based annual bonus eligibility.
• Comprehensive benefits package, including medical, dental, vision and 401(k) with company match.
• Paid time off, sick leave, and company holidays.
• Professional development opportunities and continuing education support.

We are seeking individuals to review and provide feedback on everyday money-management tips. This role focuses on common financial challenges such as managing expenses, reducing spending, and making smarter financial choices.

You will review examples of budgeting methods and evaluate practical ideas people use to stretch their income. The goal is to understand which approaches work best for real households.

The work is flexible and fully online. Applicants should have an interest in budgeting, saving money, or improving financial habits.

No formal finance background is required.