RTI Surgical Inc

Sr. Quality Engineer

RTI Surgical Inc • $100K — $120K *
West Lafayette, IN 47906In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Reposted Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering or a relevant technical discipline
  • Minimum of 6 years of quality or engineering experience, education may substitute for experience
  • Strong verbal and written communication skills
  • Proficient in technical writing and problem-solving methodologies
  • Experience with Quality Management System software
  • Proficient in Microsoft Office Suite

Responsibilities

  • Develop and maintain a strong network across functions to support Quality Assurance
  • Review and approve design project deliverables and manage risk deliverables
  • Lead investigations for product nonconformances and document actions in CAPA system
  • Participate in risk assessments and manage nonconforming product complaints
  • Perform root cause analyses and ensure effective CAPA executions
  • Assist in supplier qualification and ensure compliance through audits
  • Support validation activities and review protocols and reports
  • Initiate and manage change control processes and maintain quality documentation

Benefits

  • Relocation bonus offered
  • Onsite working environment with assigned workstation
  • Supportive company culture fostering quality improvement initiatives
  • Opportunities for internal and external audits experience
  • A focus on professional development within a transformed company structure
Full Job Description
Location: West Lafayette, IN

Salary: $100,000 to $120,000

Annual Bonus eligibility: $10,000

Relocation bonus offered!

RESPONSIBILITIES
  • Develops strong network of cross-functional colleagues, a deep understanding of business goals, project prioritization, and strong communication and facilitation skills to support the Quality Assurance function.
  • Supports product development processes inclusive of review and approval of design project deliverables, collaboration with core teams, and review and approval of risk management deliverables
  • Leads investigations for product nonconformances, process noncompliance issues, documents these appropriately in the Corrective Action / Preventive Action (CAPA) system, and demonstrates good judgment in selecting methods and techniques for obtaining solutions
  • Participates in risk assessment, review, and disposition of nonconforming products including complaints
  • Performs CAPA activities inclusive of root cause analysis, investigations, product and process disposition, risk management, and effectiveness check
  • Supports supplier qualification activities inclusive of completing and maintaining supplier qualifications, working with suppliers to address corrective actions, performing supplier audits, and assessing supplier risk
  • Supports validation activities inclusive of reviewing and approving validation protocols and reports
  • Interprets and applies appropriate sampling plans and statistical techniques
  • Ensures proper change control including initiating change plans, updating Work Instructions and Standard Operating Procedures, and documentation approvals
  • Directly supports the quality systems and process improvement initiatives
  • Supports and performs internal and external audits
  • Other duties as assigned

REQUIREMENTS

Education

  • Bachelor's degree in Engineering or relevant technical discipline


Experience

  • Minimum of 6 years of quality or engineering experience required. Experience may be substituted for education requirements.


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

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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