RTI Surgical Inc

Senior Quality Engineer - (CONTRACTOR)

RTI Surgical Inc • $90K — $120K *
Eden Prairie, MN 55347In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Reposted Today
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Job Overview by Ladders

Qualifications

  • Bachelor's or Master's degree in engineering, life sciences, or related discipline
  • 8+ years of quality experience in the medical device industry
  • Deep knowledge of global regulatory standards (FDA QSR, ISO 13485, EU MDR, MDSAP)
  • Proven success in leading cross-functional projects
  • Advanced statistical analysis and risk management expertise, Six Sigma Black Belt preferred
  • Track record of successful audits and remediation projects
  • Certifications like AATB or CTBS, Lead Auditor, ASQ - CQE, CBA, or CQA preferred

Responsibilities

  • Act as quality lead for major design and manufacturing projects
  • Own and optimize quality system processes such as CAPA and supplier quality
  • Lead complex investigations and implement corrective/preventive actions
  • Provide expertise in reliability engineering and process validation
  • Represent the company during FDA inspections and audits
  • Collaborate with executive leadership on quality strategies
  • Mentor and coach quality engineers across multiple sites

Benefits

  • Contractor role with full-time commitment
  • Onsite work opportunity in Eden Prairie, MN
  • Opportunity to mentor and influence across multiple functions
  • Potential for involvement in global projects with up to 25% travel
  • Engage with senior leadership in shaping business objectives and quality strategy
Full Job Description
Senior Quality Engineer - (CONTRACTOR)Location: Eden Prairie, MN (100% Onsite)This is a full-time contractor role supporting our Eden Prairie, MN site.

RESPONSIBILITIES
  • Act as quality lead for major design and manufacturing projects, ensuring robust risk management and compliance.
  • Own and optimize quality system processes (e.g., CAPA, supplier quality, complaint handling, statistical techniques).
  • Lead complex investigations and implement systemic corrective/preventive actions.
  • Provide expertise in reliability engineering, process validation, and design for quality.
  • Represent the company as a quality expert during FDA inspections, notified body audits, and supplier audits.
  • Collaborate with executive leadership to align quality strategies with business objectives.
  • Mentor and coach quality engineers across multiple sites or functions.

REQUIREMENTS

Education

  • Bachelor's or Master's degree in engineering, life sciences, or related discipline.


Experience
  • 8+ years of progressively responsible quality experience in the medical device industry.
  • Deep knowledge of global regulatory standards (FDA QSR, ISO 13485, EU MDR, MDSAP).
  • Proven success leading cross-functional projects and influencing at senior levels.
  • Advanced statistical analysis, risk management (ISO 14971), and Six Sigma Black Belt preferred.
  • Track record of leading successful audits and remediation projects.

Certification
  • AATB or CTBS Certification, preferred
  • Lead Auditor Certification, preferred
  • ASQ - CQE, CBA, or CQA, preferred

Skills
  • Excellent verbal and written communication
  • Technical writing
  • Problem solving methodologies
  • Microsoft Office Suite
  • Quality Management System software
  • Investigations
  • Statistical techniques

Travel
  • Up to 25% including international

SAFETY

Physical Requirement
  • Move or lift objects up to 25 pounds
  • Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays
  • Frequent (>75%) fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)

Working Environment
  • Onsite: Office environment with assigned workstation
  • Remote positions only: Home office environment with minimum distractions

About RTI Surgical Inc

RTI Surgical Holdings, Inc. is a surgical implant company. The Company processes donated human musculoskeletal and other tissues, including bone, cartilage, tendon, ligament, fascia lata, pericardium, sclera and dermal tissues, and bovine and porcine animal tissues to produce allograft and xenograft implants utilizing BIOCLEANSE, TUTOPLAST and CANCELLE SP sterilization processes, and manufactures metal and synthetic implants for distribution to hospitals and surgeons. The Company's segments include Spine, Sports Medicine, Ortho fixation, Bone Graft Substitutes and General Orthopedic (BGS and General Orthopedic), Dental and Surgical Specialties. The Company's implants are used in orthopedic, spine, sports medicine, cardiovascular, dental and surgical procedures. The Company's processing facilities are located in Alachua, Florida; Neunkirchen, Germany; and Aix-en-Provence, France. The Company distributes its implants and services in the United States and internationally.
Learn more about RTI Surgical Inc
Size
891 employees
Market Cap
$185
Industry
Healthcare
Founded
1998
5 Year Trend
+320%
NASDAQ
RTIX
* Ladders Estimates

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