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Quality Engineer (NPI)

Company: Jobleads
Location: West
Posted on: May 3, 2021

Job Description:

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate - which all help contribute to a Healthier World. At West, we are by the side of patients. The work we do impacts patients' lives each and every day - our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA"our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program. Summary: Reporting to the NPI Senior Quality Engineer or Quality Work Package Manager, this role will support NPI projects with key focus around customer specification, Validation Master Plan and protocol reviews. This person will provide the company with the technical and quality resources to manage the quality deliverables on selected NPI projects and will coordinate the necessary activities for ensuring the timely closure of internal/external quality issues on projects. Requirements: Must have a third level qualification, at a minimum to degree level, in Engineering/Quality/Science. Must have a minimum of 2 years' post graduate experience of working in a high volume manufacturing environment ideally in the Medical Device / Pharmaceutical sector. A thorough working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 is essential. Must have an in-depth knowledge of validations in a Medical Device environment. An excellent understanding of plastic process manufacturing. Good understanding of computer system validation. Must have a thorough understanding of statistics, SPC, and ideally the use of Minitab. Must have excellent communication skills both oral and written. Auditing experience to the requirements of ISO 13485 / 21 CFR Part 820 is preferred. Must be able to prioritize and organise tasks. Essential Duties and Responsibilities: Review and or approval of qualification and/or validation documentation (specifications, protocols, reports etc.) in relation to instrument, equipment, facilities, utilities, automated systems, manufacturing processes and cleaning processes including FAT, SAT, IQ, OQ, PQ phases in conjunction with program Validation representation . Review of validation documentation (protocols & reports) as a quality review against the signed off VMP and customer requirements. Review and approval of third party generated protocols and reports in conjunction with program Validation representation . Facilitate equipment process and / or Design FMEA and ensure, with the Program Manager, that the SMEs are trained to the FMEA process and updated on the relevant FMEA as required. Participate in the review and disposition of all quality attribute and variable data for the program against customer specification / drawing eg. Ppk's, Cpk's, FOT/FAT visual inspections. Lead investigations into material / product issues to ensure a thorough root cause, containment / corrective and preventive action is implemented and learnings are taken into Operations. Drive the close out of change control, deviations, quality continuous improvements identified during the project. Drive solutions, in conjunction with the appropriate department, to ensure customer related problems/issues are communicated and corrective actions are in place and closed in a timely manner. Prepare data/presentations and attend quality review meetings with the customer. Set-up of Quality controls to ensure a smooth and effective handover to Operations e.g. Drafting of the defect library and QSS during OQ with formal hand over to Operational Quality prior to PQ; set up of incoming inspections for materials etc. Implement best practices principles into West QMS as applicable. Support internal and supplier audits. Play a key role in the preparation and hosting of third party and customer audits. Trending and tracking of quality data to drive improvements eg Sampling data, Maternal reviews reports, project protocols and reports. Act in accordance with the company's Guiding Principles and adherence to the corporate Code of Conduct. Compliance to all local site Environmental, Health and Safety regulations Compliance to all local site company policies, procedures and corporate policies. Perform additional duties at the request of the direct supervisor. Delegation of Duties: When absent from the site duties and responsibilities will be delegated to the following designates Job Title Quality Work Package Manager / Senior Quality Engineer West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to kimberley.eby@ . Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.

Keywords: Jobleads, Waco , Quality Engineer (NPI), Other , West, Texas

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