Engineering Structures 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.

University Health in San Antonio is seeking board-certified Advanced Practice Providers (Acute Care Nurse Practitioners and Physician Assistants) to join a high-acuity, multidisciplinary critical care team at University Hospital. This role supports a 24/7, high-intensity ICU model serving complex patient populations including solid organ transplantation, cardiothoracic surgery, cardiac care, and ECMO therapy. Our collaborative model integrates Surgical Critical Care and Anesthesia Critical Care services to deliver comprehensive, patient-centered care across all ICU service lines.

About the Program The critical care team is structured to provide:

• 24/7 on-site coverage by Faculty Intensivists and Advanced Practice Providers (APPs)
• Support from multidisciplinary Residents and Critical Care Fellows
• Clearly defined structures and processes to ensure quality and consistency of care
• Real-time collaboration across service lines to develop and implement conjoint care plans

Qualifications

• Board-certified Acute Care Nurse Practitioner (ACNP) or Physician Assistant
• Active or eligible for Texas licensure
• ICU experience strongly preferred
• Demonstrated ability to thrive in a high-acuity, team-based environment
• Strong clinical judgment, communication, and collaboration skills

Why Join University Health? University Health is proud to offer a supportive and rewarding work environment, including:

• Competitive total compensation package
• Affordable medical insurance and comprehensive benefits
• Loan repayment program up to $50,000 over 5 years
• Annual professional business expense allowance plus CME days
• Annual tuition reimbursement and certification support
• Deferred compensation retirement plan with employer match
• Generous paid time off
• Opportunity to work alongside highly skilled and respected physicians
• Strong culture of teamwork and peer camaraderie

About University Health University Health is a nationally recognized academic health system committed to delivering high-quality care, advancing medical education, and improving community health across South Texas.

Why San Antonio?

San Antonio offers an exceptional quality of life with a low cost of living, rich cultural heritage, a vibrant culinary and arts scene, and easy access to the Texas Hill Country. The city combines major metropolitan amenities with a welcoming, family-friendly atmosphere and year-round outdoor activities.

Director of Operations

Location: On-Site

Reports To: CEO

Direct Reports: Machinists, Plastics Technicians, Assemblers, Shipping, Technical Coordinator (9 total)

Compensation

                 Total Compensation Target: $120,000 - $150,000+ annually

                 Base Salary: $80,000 - $90,000 annually

Performance bonus is calculated quarterly based on measurable operational financial results that are within the Director of Operations control. The structure is designed to reward ownership, accountability, and measurable operational improvement.

                 Bonus is tied to:

·      Operational Contribution Margin (OCM)

·      On-Time Delivery (OTD)

·      Quantity Returned Rate (QRR)

·      CEO Evaluation

Role Overview

The Director of Operations owns Operational Contribution Margin (OCM) through disciplined execution of production, purchasing, labor efficiency, scrap control, supplier accountability, and on-time delivery performance.

This is a hands-on leadership role in a growing manufacturing company. The Director of Operations is directly responsible for protecting and improving margin by eliminating operational waste, enforcing purchasing discipline, improving production flow, and holding suppliers and internal teams accountable.

This position holds full authority over production scheduling, purchasing strategy, supplier performance, incoming quality enforcement, inventory discipline, and backlog management.

Success in this role is measured by Operational Contribution Margin, quality control, and reliable on-time delivery.

What This Role Must Know

A successful candidate should have strong working knowledge of:

• Manufacturing process flow and bottleneck identification
• Production scheduling and throughput management
• Purchasing discipline and supplier accountability
• Inventory control and working capital management
• Quality control and defect reduction systems
• Operational margin drivers within a manufacturing environment
• Lean operational principles and practical process improvement
• Basic financial literacy, including cost drivers and margin impact

This role requires the ability to translate operational improvements directly into financial performance.

What This Role Must Be Comfortable With

The right person for this role is comfortable with:

• Owning operational results end-to-end
• Working inside a small business environment where systems must be built and improved
• Making decisions with incomplete information and solving problems quickly
• Managing both production personnel and supplier relationships
• Implementing operational discipline and accountability across the shop floor
• Balancing operational efficiency with product quality and delivery performance
• Being directly responsible for measurable operational performance metrics
• Leading operational improvement initiatives rather than maintaining the status quo

This role is best suited for someone who prefers building and improving systems rather than simply maintaining existing processes.

Candidate Profile

The strongest candidates for this role typically come from environments where they have:

• Managed manufacturing operations or production systems
• Driven measurable improvements in efficiency, quality, or margin
• Implemented process improvements in growing manufacturing organizations
• Demonstrated the ability to take ownership of operational performance

This is a hands-on operational leadership role, not a purely administrative position.

Compensation

Compensation includes a competitive base salary plus a performance-based bonus tied directly to Operational Contribution Margin, Quantity Return Rate (QRR), and on-time delivery metrics.

This structure rewards disciplined operational leadership and measurable financial improvement.

Ideal Candidate Profile

• Experience leading production in a small-to-mid-sized manufacturing environment
• Has personally owned purchasing and supplier accountability
• Has implemented measurable scrap reduction and efficiency improvements
• Comfortable working without corporate support infrastructure
• Thinks in terms of financial outcomes, not just operational activity
• Speaks in numbers and measurable results
• Demonstrates ownership mentality and accountability

What Success Looks Like

Within 6–12 months:

• Operational Contribution Margin stabilizes and improves
• Scrap is measured and trending downward
• Purchasing is consolidated and disciplined
• Supplier credits are tracked and recovered
• Backlog is stable and predictable with lead time improvement
• CEO operational involvement is significantly reduced

This is a leadership role for someone who wants ownership, accountability, and the opportunity to materially impact a growing manufacturing company.

Sign-On Bonus Opportunity!

Eligible candidates may qualify for a sign-on bonus* as part of their total compensation package. Bonus eligibility and payout structure will be discussed early in the interview process.

A Nursing Role Built for Focused, One-on-One Care

At Care Options for Kids, pediatric home health nursing is intentionally different. Instead of juggling multiple patients, alarms, and constant interruptions, you provide dedicated, one-on-one care in the home, allowing you to focus fully on your patient and use your clinical judgment with confidence.

In this role, you'll care for pediatric patients with high acuity needs while building consistent relationships with both the child and their family. Nurses who thrive here value autonomy, continuity of care, and the ability to deliver skilled nursing in a calm, controlled environment, backed by real clinical support whenever it's needed

If you're an RN looking for a role where you can practice nursing with focus, purpose, and support, this position was designed with you in mind.

Care Options for Kids Benefits

• Weekly Pay and Direct Deposit
• Paid Time Off (PTO) and flexible scheduling
• Medical, Dental, and Vision Insurance
• 401(k) Retirement Plan
• Employee Referral Bonus Opportunities
• Career Advancement Opportunities
• Training and Competency Development
• Respiratory Therapists on Staff to Provide Training and Mentorship
• 24/7 On-Call Clinical Support

Support That Keeps You Safe and Confident

• Easy-to-use Employee Portal that puts you in control, request shifts that fit your schedule and preferences, earn Care Bucks rewards, and stay connected to the COFK community.
• 24/7 on-call clinical support whenever you need it
• Training and competency support for high-acuity care
• Clear care plans and physician orders
• PPE provided in every home, including masks, gloves, and hand sanitizer, with care aligned to CDC safety guidelines
• A dedicated team focused on nurse safety and success

Requirements

• Current, active Texas RN license
• Current BLS CPR card (obtained in-person, not online)
• G-tube, trach, vent experience, or willing to train

Care Options for Kids is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

*Restrictions Apply. Connect with Talent Acquisition Specialist for details on Sign On Bonus eligibility and payout schedule.

#RDNUSATX

Salary:

Sign-On Bonus Opportunity!

Eligible candidates may qualify for a sign-on bonus* as part of their total compensation package. Bonus eligibility and payout structure will be discussed early in the interview process.

A Nursing Role Built for Focused, One-on-One Care

At Care Options for Kids, pediatric home health nursing is intentionally different. Instead of juggling multiple patients, alarms, and constant interruptions, you provide dedicated, one-on-one care in the home, allowing you to focus fully on your patient and use your clinical judgment with confidence.

In this role, you'll care for pediatric patients with high acuity needs while building consistent relationships with both the child and their family. Nurses who thrive here value autonomy, continuity of care, and the ability to deliver skilled nursing in a calm, controlled environment, backed by real clinical support whenever it's needed

If you're an RN looking for a role where you can practice nursing with focus, purpose, and support, this position was designed with you in mind.

Care Options for Kids Benefits

• Weekly Pay and Direct Deposit
• Paid Time Off (PTO) and flexible scheduling
• Medical, Dental, and Vision Insurance
• 401(k) Retirement Plan
• Employee Referral Bonus Opportunities
• Career Advancement Opportunities
• Training and Competency Development
• Respiratory Therapists on Staff to Provide Training and Mentorship
• 24/7 On-Call Clinical Support

Support That Keeps You Safe and Confident

• Easy-to-use Employee Portal that puts you in control, request shifts that fit your schedule and preferences, earn Care Bucks rewards, and stay connected to the COFK community.
• 24/7 on-call clinical support whenever you need it
• Training and competency support for high-acuity care
• Clear care plans and physician orders
• PPE provided in every home, including masks, gloves, and hand sanitizer, with care aligned to CDC safety guidelines
• A dedicated team focused on nurse safety and success

Requirements

• Current, active Texas RN license
• Current BLS CPR card (obtained in-person, not online)
• G-tube, trach, vent experience, or willing to train

Care Options for Kids is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

*Restrictions Apply. Connect with Talent Acquisition Specialist for details on Sign On Bonus eligibility and payout schedule.

#RDNUSATX

Salary: