Quality Control Engineer

POSITION TITLE: QC EngineerREPORTS TO: VP, Regulatory, Quality and Product SupportJOB SUMMARY: The Quality Control Engineer is responsible for ensuring that medical devices at Turbett Surgical meet established quality standards and regulatory requirements. This role supports product quality through inspection, testing, data analysis, and continuous improvement initiatives across manufacturing and supplier processes. KEY RESPONSIBILITIES:Develop, implement, and maintain quality control procedures, inspection plans, and test methods.Perform and oversee incoming, in-process, and final product inspections. Track and analyze quality and engineering related data to identify trends, root causes and opportunities for improvement. Drive comprehensive root cause investigations (e.g., NCMRs, deviations, CAPAs using DMAIC principles, ensuring effective implementation and verification of corrective actions. Collaborate with manufacturing, R&D, and supplier quality teams to resolve quality issuesEnsure complaint with applicable regulations and standards (i.e. FDA , ISO 13485)Review and approve incoming inspection records, test results and batch documentationReview and confirm shipment forms and parts. Crosschecks inventory movements for accuracy Inspect parts or product for recertification program and complete appropriate recertification documentationManages internal equipment calibration processesSupport the creation of service kits for complaints or preventative maintenance repairs. Supports complaints by troubleshooting potential defects and performs investigation tasksParticipate in internal and external audits, including regulatory inspectionsSupport validation activities (IQ/OQ/PQ) and perform Gage R&R studies for inspection and test processesAssist in supplier qualification and performance monitoring Drive continuous improvement initiatives using Lean/Six Sigma methodologies KNOWLEDGE, SKILLS & ABILITIES:Education Bachelor’s degree in Engineering, Life Sciences, or related field ·       Experience 2-5+ years of experience in quality control or quality engineering within the medical device or other regulated industry. Experience with inspection tools, measurement systems, and statistical analysis. ·       Required Skills and Competencies:o  Strong knowledge of quality systems and regulatory requirements (e.g., FDA 21 CRF Part 820, ISO 13485).o  Proficiency in root cause analysis tools (e.g., Fishbone, 5 Whys, FMEA)o  Experience with statistical methods and software (e.g., Minitab), with practical application of Statistical Process Control (SPC), Processes Capability (Cpk/Ppk), and sampling plans.o  Expertise in reading and interpreting engineering drawings, specifically utilizing Geometric Dimensioning and Tolerancing (GD&T). o  Technical writing experience (procedural, work instructions and reports)o  Strong attention to detail and documentation skills o  Excellent problem solving and cross- functional collaboration abilities Preferred Qualifications:Certified Quality Engineer or similar certification Experience with risk management (ISO 14971) Familiarity with electronic quality management systems (eQMS)Six Sigma Certification (Green Belt or higher) Proficient in Microsoft Office SuiteWorking Conditions:Combination of office and manufacturing floor environmentMay require use of personal protective equipment (PPE)Occasional travel for supplier audits or site supportBenefits. As a full-time employee, you will also be eligible to participate in our current benefits package, which consists of health and dental insurance, 401K plan and vacation policy as further laid out in Turbett Surgical’s Employee Handbook.Compensation Range: $60,000 to $75,000 per yearThe listed base pay range is a good faith representation of current potential base pay for a successful full time applicant. It may be modified in the fuure. Pay is determined by factors including experience, relevant qualifications, internal equity, and location.Turbett Surgical, Inc is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, predisposing genetic characteristics, marital or familial status, military or veteran status, citizenship, or any other characteristic protected by federal, state or local law.