Product Quality Engineer
hace 3 semanas
About the role
Participate in changes within the project portfolio in Sustaining Eng. Group, and hereby achieve:
- Compliance with internal and external requirements according to standards, customer, and authorities
- Ensure quality system is developed, maintained, and improved.
- Assure Process Validation and Change Control Request system is followed accordingly.
- Support as leader on quality issues or non-conformities raised from the project-change.
Key responsibilities
- Update and develop quality procedures, quality specifications as required in the project-change.
- Draw up and/or follow up on internal deviations, rationales, statements, and preventive actions. Supporting the quality system in the adequate handling, for instance, non-conformities activities, CAPA activities.
- Responsible for Updating Risk Management Plan, including Use/Design FMECA and Process FMECA within a new project/change.
- Responsible for identifying all affected documents on a change/project (DMR).
- Participate in design review and design examination.
- Review protocols and reports (documentation) regarding verification/validation processes, in applicable phases.
- Obligated to prevent the occurrence of risk ad of adverse impact on product quality, function, performance, usability, safety, and its intended use.
- Responsible for Sterilization Evaluation Report.
- Act as advance impact assessor in a CCR.
Requirements
- Bachelor's degree in engineering or similar technical education (required)
- Min 3 years on expiring working in similar position (preferred)
- Experience from Medical Device Industry or other regulated industry (preferred)
- Experience with cross organizational projects (preferred)
- Knowledge of process validation (required)
- Fluent in oral and written English (required)
- Experience on measurement techniques, root cause investigation and statistics (required)
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Equal opportunities
Convatec 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 Representatives
Convatec 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.
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