- Exhibit a strong "quality first" mentality and ensure that product and process quality are held to the highest standard.
- Provides guidance and review of Design Control/ DHF documents for development of components and medical devices.
- Provides review of Risk Management documents (including Design and Process FMEA)
- Review and approve R&D engineering protocols and summary reports; makes recommendations.
- Work with R&D to determine equipment qualification and validation activities including providing quality oversight to risk assessments where applicable.
- Review and evaluate change control for Design History and product risk impact.
- Works with minimal supervision to evaluate gaps and lead projects to close them.
- Work closely with and provide guidance to research and development teams.
- Identify critical quality attributes for development materials and components.
- Partner with and support the New Product Development Quality team in product development activities including but not limited to Failure Investigations, CAPAs, Non-Conformance assessments, audit findings, deviations, and QMS procedural improvements.
- Support the development of product development QMS procedures and work instructions.
- Work cross-functionally with individuals and extended teams to ensure success of projects.
- Drive continuous quality improvement projects.
- Assure escalation of quality related issues to ensure effective remediation.
- Other duties as assigned.
- Bachelor's degree in engineering required.
- Minimum 5 years of experience in a regulated Quality Systems/ Quality Assurance/ Design Quality role.
- Ability to work independently, multi-task and thrive in a fast-paced environment.
- Experience with qualifications, Quality Risk Management
- Experience with quality systems such as ISO 13485, 21 CFR 820
- Excellent written and verbal communication skills
- Proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point
- Experience with Medical Device Product Development Life Cycle Activities, Verification / Validation Activities, Risk Management, DHF Activities
- Experience with quality systems such as ISO 14971, 21 CFR 820.30
- Experience with MasterControl, SAP, Share Point, Teamcenter
- Able to be aware of all relevant SOPs as per Company policy and Quality Manual
- Able to comply with the company's safety policy at all times.
- Able to comply with the company's quality policy at all times.
- 5%: Up to 13 business days per year
- Sedentary - exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met
- Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
- Must maintain the ability to work well with others in a variety of situations.
- Must be able to multi-task, work under time constraints, problem solve, and prioritize.
- Ability to make independent and sound judgments.
- Observe and interpret situations, analyze and solve problems.
- Maintain high attention to detail, accuracy, and overall quality of work.
- Effectively communicate and interface with various levels internally and with customers.
- Able to be aware of all relevant SOPs as per Company policy and Quality Manual
Sr. Quality Engineer - Exton, United States - West Pharmaceutical Services
Description
Job Summary
:In this role, the Senior Quality Engineer is accountable for supporting research and development activities within a multi-functional team environment for medical devices and components. The Senior Quality Engineer is an integral member of the Quality team with the overall mission to lead the Quality activities related to Metrology, Receiving Inspection, and Verification Engineering teams. Additionally, this role will identify and implement improvements within the Quality Management System. The Sr. Quality Engineer will actively ensure products meet quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and other regulatory requirements.
The Sr. Quality Engineer will also execute transactions in relevant GMP systems (MasterControl, SAP, Share Point) and other relevant quality functions as applicable including site audit support.
Essential Duties and Responsibilities:
Basic Qualifications:
Preferred Knowledge, Skills and Abilities:
Travel Requirements:
Physical & Mental Requirements:
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West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.