RTI Surgical Inc

Sr. Quality Engineer

RTI Surgical Inc • $85K — $110K *
Alachua, FL 32615In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Reposted 2 days ago
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in relevant technical discipline
  • 6+ years of experience in medical device, pharmaceutical, or regulated industry
  • Advanced degree may substitute for some experience
  • Preferred certifications: AATB or CTBS, Lead Auditor, ASQ - CQE, CBA, or CQA
  • Strong verbal and written communication skills
  • Proficient in Microsoft Office and Quality Management Systems
  • Skilled in problem solving and statistical techniques

Responsibilities

  • Lead cross-functional project teams to improve manufacturing processes
  • Supervise Quality Assurance Engineering team and manage performance
  • Review KPI data for continuous improvement with operations
  • Oversee validations and risk management for regulatory submissions
  • Conduct problem-solving initiatives for quality and product development
  • Edit investigations and presentations for quality initiatives
  • Perform other assigned duties

Benefits

  • Onsite work environment with designated workspace
  • Work alongside a team supported by a leading European private equity firm
  • Opportunity for professional development and career advancement
  • Engagement in meaningful projects impacting product quality and patient safety
Full Job Description
Location: Alachua, FL

RESPONSIBILITIES
  • Serves as a lead core team member of cross functional project teams whose responsibilities include coordinating deliverables for the improvement of processes across the manufacturing facility
  • Supervises the Quality Assurance Engineering team including performance management, corrective action, hiring and selection, and allocation of engineering support as it relates to quality assurance initiatives
  • Reviews quality Key Performance Indicator (KPI) data and actions to ensure continuous improvement in collaboration with various operations value streams
  • Reviews validations and risk management activities to support regulatory submissions, sustaining activities, and product launches are on time and have a high level of customer and patient focus
  • Leads and conducts problem solving through change management, nonconformance workflows, and continuous improvement or new product development initiatives
  • Reviews and edits nonconformance investigation and disposition phases for team members and assists in the preparation and presentation of materials for quality initiatives
  • Other duties as assigned

REQUIREMENTS

Education

  • Bachelor's degree in relevant technical discipline


Experience
  • 6+ years of relevant medical device, pharmaceutical, or other regulated industry experience.
  • *Combination of advanced degree and experience may be considered.

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
  • N/A

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

Montagu Private Equity ("Montagu"), a leading European private equity firm, acquired RTI in 2020 and has supported the transformation of the company to its next level of potential.

#LI-Onsite

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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