Quality Manager jobs in United States
cer-icon
Apply on Employer Site
company-logo

Carwild Corporation · 1 day ago

Quality Manager

positionNew London, CT
timeFull-time
remoteOnsite
senioritySenior Level
date5+ years exp

Carwild Corporation is seeking a Quality Manager to ensure product and process excellence across our organization. This role applies quality principles to resolve issues, support new and sustained product development, lead investigations, and maintain compliance with regulatory standards.

Health CareManufacturingMedical Device

Responsibilities

Ensure compliance with Quality System and regulatory requirements (ISO13485, ISO14971, FDA 21 CFR Part 820)
Support new and sustained product development, including supplier validation (IQ, OQ, PQ)
Act as QA representative for design control projects
Lead complex complaint investigations using root cause analysis and corrective actions
Apply risk analysis tools (FMEA, Hazard Analysis, Control Plans, Risk Management Reports)
Provide input for test protocols and statistical analysis of complaint data
Develop sampling plans for inspections and production
Support internal/external audits (FDA, ISO, customer assessments)
Assist with supplier development and qualification
Deliver training on quality tools and procedures
Prepare and file regulatory and quality documentation

Qualification

QA methodologiesValidation IQValidation OQValidation PQStatistical knowledgeISO 13485Supplier developmentProfessional certificationsContinuous improvementRegulatory documentation

Required

B.S. in Engineering or related technical discipline (Chemistry, Biology, Physics, Mathematics)
Minimum 5 years in a regulated industry (medical device preferred; aerospace, automotive, pharmaceutical acceptable)
Proficient in QA methodologies (FMEA, SPC, Root Cause Analysis, DOE)
Experience with validation (IQ, OQ, PQ)
Strong statistical knowledge (SPC, Cpk/Ppk, AQL, OC curves) and tools like Minitab
Familiarity with ISO 13485 and FDA GMP/QSR
Supplier development and qualification experience

Preferred

Professional certifications (CQE, CQA, Lean Six Sigma)
Continuous improvement program implementation
Knowledge of EU MDR 2017/745

Company

Carwild Corporation

twittertwitter
company-logo
Carwild Corporation with Medsorb Dominicana is a contract medical manufacturer with facilities in New London, Connecticut and San Pedro de Macorís, Dominican Republic.
dateFounded in 1978
location
New London, Connecticut, USA
people-size501-1,000 employees
web-link
http://www.carwild.net/

Funding

Current Stage
Late Stage

Leadership Team

leader-logo
Rebecca Wildstein
Chief FInancial Officer
linkedin
Company data provided by crunchbase