Project Quality Sr Engineer

About ConvatecPioneering trusted medical solutions to improve the lives we touch: Convatec 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, we provide our products and services in around 90 countries, united by a promise to be forever caring. Convatec’s revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit convatecgroup.com.Role overview: As a Senior Engineer, Quality Project you will assure the good environment of quality engineering team is established. Maintain trained and motivated personnel in the areas to his/her responsibility. Lead the team to assure compliance with regulations, standards, QMS internal procedures on a New Project (CCR). Manage Process Improvements (OFI), Validation & Revalidations, Risk Management, and Customer complaints investigations which are directly handled by the Projects Quality Engineer (PQE). Ensure quality issues are properly addressed from non-conformities, maintain quality indicators and internal deviations ensuring activities are handled properly and on time.Main responsibilitiesSupervise the activities of personnel under his/her responsibility.Evaluate the necessary resources to perform tasks in respective areas. Identify needs and perform training for personnel in charge. Develop the personnel’s skills under his/her responsibility.Maintain communication with other areas regarding quality problems or improvements (production, maintenance, engineering, logistics, suppliers, etc.). Promote ideas for continuous improvement of quality with the aim of system simplification.Follow up on NC’s/PPMs trending as well as VPM.Assure quality monthly report.Review and approve quality specifications documents. Online documentation, etc.Process control related activities.Oversee and coordinate investigations related to process failures, customer complaints, and other quality issues through his/her resources.Ensure NC processes/activities are followed adequately and under applicable procedures.Review objective evidence to complete investigations and ensure correct NC closure and effectiveness.Issue NC/CAPA when needed according to procedures; participate in Review Board meetings.Ensure final dispositions are well documented and follow proper procedures.Support the quality system with adequate handling of non-conformity activities, corrective and preventive actions.Support defining a classification of all Non-Conformities based on risk. Review, update and develop procedures, instructions, and quality specifications as needed.Follow up the QA role as per NC procedure (Originator, Owner, Quality Reviewer, Approver, etc.) as needed.Provide support in various areas where experience and technical knowledge are useful (production, microbiology, systems, etc.). Lead and maintain communication with other departments MX / DK regarding quality problems.Participate in projects as the main responsibility through PQEs, ensuring regulations or other applicable standards are met.Support risk management system when needed.In cooperation with Engineering, ensure resource and planning for revalidation activities is well handled.Ensure validation documentation is filled following procedures and applicable regulations through the PQE in charge.Support review and approval in IQ, OQ and PQ validations as well as in PSE in all systems applied, in collaboration with project leader.Support review and approval in management of software validations / test equipment and method validation.Collaborate on validation of molds and molding machines providing support as Quality Engineering when needed.Comply with the company quality policy.QualificationsBachelor’s degree (Mechanical, Electronic, Industrial or similar) required.Minimum 3 years’ experience in Engineering areas, required.Verbal and written English, required.Strong experience with Quality Management System (QMS) and Quality Control Charts (histogram, Pareto, process capability calculations, control charts, etc.), required.Strong experience with Quality Management Tools (brainstorms, flow diagrams, cause and effect diagrams, etc.), required.Focus on continuous improvement mindset, required.Strong ability to capture, describe and communicate ideas to the team; Auditor skills, preferred.Supervisor experience, preferred.Training/Knowledge on MDSAP, MDR, FDA QSRs and GMPs, ISO 13485, J-PAL/Ordinance No.169, EU and Canadian medical devices regulation, or similar regulations, preferred.Familiar with common computer software packages. MS Office, Lotus Notes, etc., required.What you’ll getCompetitive salary + bonus • Training & development • Collaborative, supportive cultureReady to join us?At Convatec, we’re pioneering trusted medical solutions to improve the lives we touch. If you’re ready to make a real impact, apply today and help us bring our Forever Caring promise to life.#LI-ML1Scam awareness & equal opportunityBeware of scams online or from individuals claiming to represent ConvatecA formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at careers@Convatec.com.Equal opportunitiesConvatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.Notice to Agency and Search Firm RepresentativesConvatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.Already a Convatec employee?If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View "Convatec Internal Career Site - Find Jobs". Thank you #J-18808-Ljbffr