Sr. Quality Engineer
Sr. Quality Engineer
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1 Vacancy
Job Description
At West were a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily Wests indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future
Theres no better place to join an inclusive community of professionals with opportunities for lifelong learning growth and development. Supported by benefit programs we empower the physical mental emotional and financial health of our team members and their families.
We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.
Job Summary
Essential Duties and Responsibilities
- Lead project planning activity and develop comprehensive project plans including scope timelines budget resources and project success criteria. Gain buy-in from project team and ensure an inclusive approach to project planning. Proactively identify gaps and risks to project success and implement mitigation strategies to minimize impact.
- Collaborate with cross-functional teams internal and external to the laboratory to coordinate project execution and ensure that project objectives and success criteria are met.
- Provide Quality Engineering direction to multiple concurrent product development programs to ensure product and process compliance to all applicable regulatory and cGMP requirements including ensuring all relevant safety procedures are employed.
- Author review and/or approve design history documentation and design manufacturing documentation (e.g. product specifications design verification and validation activities FMEA risk documents test methods protocols reports manufacturing records etc.)
- Lead the development and maintenance of product or process risk and hazard analysis in accordance with West policies and procedures and ISO standards.
- Lead and manage QMS activities including CAPA Failure Investigation Non-Conformance assessment audit findings issue reviews document control change controls configuration management etc. Provide direction on any nonconformance deviation or excursion that may occur and drive to closure. Author and review product development QMS procedures and work instructions.
- Meet company and departmental goals in the continuous improvement of all products services and processes including the West QMS.
- May work independently and with project teams to develop design control deliverables including quality plans manufacturing and inspection documentation test methods and any other necessary quality records. Provide quality reports and review trending on assigned areas of responsibility.
- May support quality assurance improvement activities by evaluating products processes or materials in order to develop control or improvement strategies intended to improve the customers experience.
- May assumes responsibility for various assigned projects designed to improve product quality reduce costs and/or validate facility products or processes including development and implementation of any new or required inspection methods and in-process Statistical Process Control programs.
- May perform DOEs (Design of Experiments) to help improve and optimize new and/or existing plant processes or job protocols and identify and remedy equipment and/or process documentation gaps and provide appropriate training where needed.
- May have people management responsibilities.
- Other duties as assigned.
Education
- Bachelors Degree in Engineering or Science or equivalent experience required
Work Experience
- Minimum 5 years of experience in a regulated industry (e.g. Medical Device) including Product Development Product Manufacturing and Post Market Surveillance Activities required and
- Demonstrated experience (4 years) independently defining planning and executing projects in highly regulated environments with a track record of success required and
- In-depth knowledge of cGMP regulations ISO 17025 ISO 11040 ISOCFR 820 ISO 14971 required and
- Proficiency in standard project management tools and software (e.g. Microsoft Project Excel) for planning tracking and reporting project activities and proficient in statistical software Windows OS Microsoft Office Suite including Word Excel and Power Point required and
Preferred Knowledge Skills and Abilities
- Experience with MasterControl SAP Share Point Teamcenter
- Experience with ISO 11040 ISO 11607
- Expertise in quality management tools. Standards policies and procedures APQP PPAP MSA SQC etc
- Strong working knowledge of quality systems of the respective ISO norms
- Working knowledge of supplier quality management from product development to mass production.
- Strong project management skills
- Proficient in computer system applications (SAP master controls etc) communication skills
- Excellent critical reading and writing skills
- Problem solving including root cause failure analysis methods
- Be aware of all relevant SOPs as per Company policy as they relate to this role
- Able to comply with the companys safety and quality policies at all times
License and Certifications
- ManufacturingSix Sigma Green Belt Certification or Black Belt Upon Hire preferred
- QualityCertified Quality Technician-ASQ (CQE or CQA) Upon Hire preferred
- SO 17025 Auditor or Lead Auditor Training / Certification Upon Hire preferred
Travel Requirements
Physical Requirements
Additional Requirements
- Exhibit a strong quality first mentality and ensure that product and process quality are held to the highest standard.
- Excellent written and oral communication and interpersonal abilities with the capacity to communicate complex technical concepts to diverse stakeholders.
- Ability to work independently multi-task and thrive in fast-paced environment.
- Strong problem-solving skills including root cause failure analysis methods.
- 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.
- Critical reading skills and maintain high attention to detail accuracy and overall quality of work.
- 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.
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 orderto apply to West please send an email to . 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.
Required Experience:
Senior IC
Employment Type
Full Time
