Project Quality Sr Engineer

Project Quality Sr EngineerConvatec is a global medical products and technologies company focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care and Infusion Care. With more than 10,000 colleagues across about 90 countries, Convatec is dedicated to improving patient outcomes, preventing infection, and reducing care costs. Convatec’s 2024 revenues exceed $2 billion. Our mission: to be forever caring.ResponsibilitiesSupervise and train quality personnel within assigned projects.Ensure compliance with applicable regulations, standards and the QMS, including new project (CCR) documentation.Lead investigations of non‑conformities, process failures and customer complaints; close cases with effective CAPA.Monitor NC, PPM, VPM trends and produce monthly quality reports.Review and approve quality specification documents, procedures and specifications.Support validation and revalidation activities (IQ, OQ, PQ, PSE) and software/test‑equipment validation.Participate in risk‑management activities and safety reviews.Coordinate with engineering, production, logistics, suppliers and other departments to resolve quality issues.Maintain quality indicators and internal deviation records in accordance with QMS procedures.Collaborate with the engineering department on resource planning for revalidation and validation documentation.QualificationsCollege degree in Mechanical, Electrical, Industrial Engineering or related field.Minimum 3 years in an engineering role with quality responsibilities.Strong experience in QMS and quality control chart analysis (histogram, pareto, process capability, control charts).Proficiency in quality management tools (brainstorming, flow diagrams, cause‑and‑effect diagrams).Relevant knowledge of MDSAP, MDR, FDA QSR, GMP, ISO 13485, J‑PAL/Ordinance No. 169 and other medical‑device regulations.Excellent written and verbal English.Experience in supervising personnel and, preferably, training sub‑ordinates.Strong analytical and communication skills; ability to capture, describe and convey ideas.Familiarity with common computer packages – MS Office, Lotus Notes, etc.BenefitsCompetitive salary plus performance bonus.Training and development opportunities.Collaborative, supportive company culture.Equal Opportunity StatementConvatec provides equal employment opportunities for all employees and applicants. No discrimination is tolerated on the basis of race, religion, creed, color, national origin, citizenship, ancestry, sex, age, marital status, physical or mental disability, sexual orientation, gender identity, military or veteran status, genetic characteristics or any other legally protected basis.Recruitment PolicyAll Convatec hiring follows a formal recruitment process. If you receive an unsolicited job offer or invitation from an individual or agency claiming to represent Convatec, do not disclose personal information or pay any fees. Report suspicious approaches to careers@Convatec.com.Seniority LevelMid‑Senior levelEmployment TypeFull‑timeJob FunctionQuality AssuranceIndustriesMedical Equipment ManufacturingAdditional InformationReferrals increase your chance of interview by 2×.If you are an active Convatec employee, please do not apply here. Use the Convatec Internal Career Site via Workday. #J-18808-Ljbffr