Quality Engineer

RXinsider LTD.; Williamsport (Lycoming County); On-site; USD 75,000 - 115,000; Full time

Job summary

West Pharmaceutical Services, Inc. seeks a QA professional to lead quality assurance activities supporting new product development and validation. You will perform audits, CAPA, and support ISO 13485 compliance across manufacturing, engineering, and supply chain.

You will work with customers and internal teams to investigate complaints, develop validation protocols (IQ/OQ/PQ), and ensure proper documentation and adherence to quality policies. Travel up to 10% may be required.

Qualifications

• Bachelor’s degree preferably in technical discipline; Science, Engineering, Quality Assurance, or a related field.
• Strong knowledge of statistics and use of Minitab.
• Excellent communication and problem solving skills.
• Familiarity with SAP or MasterControl is a plus.

Responsibilities

• Plan, schedule, execute & communicate all items regarding quality issues, complaints, validations & other projects to QA Manager and/or other interested parties.
• Provide technical assistance for developing and maintaining measurement routines for the vision measuring system.
• Provide quality assistance in support of new product development and validation.
• Support customer complaint process and CAPA actions.
• Perform audits of departments and participate in customer/supplier/corporate audits.

Job description

At West, we’re 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, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

There’s 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

Plan, schedule, execute & communicate all items regarding quality issues, complaints, validations & other projects to QA Manager and/or other interested parties. Provide technical assistance for developing and maintaining measurement routines for the various vision measuring system. Provide quality assistance in support of new product development and validation. Support customer complaint process. Provide quality assistance including SPC support with facility manufacturing, engineering, maintenance, shipping and warehouse functions. Be a quality resource in the improvement of all aspects of plant operations and in the plant’s relations with its customers and suppliers. Perform all duties associated with the auditing and documentation of compliance related items against ISO standards.

Essential Duties And Responsibilities

• Provides technical and quality support by:
  • Assisting facility and design development personnel as needed for engineering/projects.
  • Providing guidance and training to all QA personnel about new operation and programming of vision system equipment.
  • Providing backup support to QA Manager and/or QA Supervisor, as needed.
  • Assisting in the investigation of customer complaints to ensure timely response.
  • Assisting in maintenance and improvement of facility required quality systems including ISO 13485 and HACCP.
  • As required, work with Manufacturing, Engineering, Sales, the Customers and Suppliers to resolve issues on new products. (This may require travel.)
• Become knowledgeable in all areas of the Q.A. Department and work with the various functions within Q.A. to resolve internal issues as they arise.
• Perform audits of the various departments / functions as directed by the Q. A. Manager.
• As required, participate and or lead Customer meetings / audits, Supplier meetings / audits and corporate audits.
• Work with management and technical staff in performing root cause failure analysis and implementing corrective and preventative actions to preclude recurrence (CAPA).
• Ability to closely interact with customers to understand and integrate those requirements into West manufacturing and quality system requirements
• Work independently and with project teams to develop design control deliverables including quality plans, manufacturing and inspection documentation, test methods, and any necessary records for filing tooling product history files
• Complete dimensional analysis for OQ & PQ as needed to include capability, normality and transformation of data when required.
• Create validation protocols (IQ, OQ & PQ) and obtain customer approval, when applicable.
• Complete validation reports and submit to internal and external teams as applicable.
• Aid in validating and reviewing validations of equipment, products and processes.
• Developing and execute Gauge R&R studies to ensure confidence in defined measuring techniques. When applicable, work with QA Supervisor to develop/execute plan for improvements (equipment, training, etc.).
• Assist Measuring Techs in the evaluation of and possible improvements to defined measurement routines, fixtures and troubleshooting of problems related to the vision measuring system.
• As directed by the QA Manager, represent the facility QA, engineering, and manufacturing groups for new products. As a member, ensure plant S.O.I.’s and Corporate G.O.P.’s are being followed and ensure all necessary testing and evaluations have been completed prior to completion and final approval.
• Drive site and departmental goals/KPI’s in the improvement of Cost of Poor Quality and Yield Opportunity to 100%
• Other duties as assigned

Education

• Bachelor’s degree preferably in technical discipline; Science, Engineering, Quality Assurance, or a related field.

Work Experience

• Background in SPC, Root Cause and Corrective Action (Exposure to 8D or A3 methodology preferred).
• Experience: 3+ Years as a quality or engineering professional in a manufacturing environment.

Preferred Knowledge, Skills And Abilities

• Must be familiar with computers and various software programs.
• Strong knowledge, understanding of statistics and use of Minitab.
• Must be able to use the various pieces of measuring / testing equipment. (I.e. calipers, micrometers, comparators, height gages, vision and data collection systems.)
• Excellent communications (including both written & oral methods), interpersonal, problem solving (including root cause failure analysis methods), planning/organizational, negotiating and computer skills required (especially MS Office applications & statistical analysis systems); general understanding of manufacturing and plant operations are also required.
• Strong customer facing experience
• Background in plastics is preferred.
• Familiarity with SAP, Master Control or similar systems and databases, a plus.
• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times.

License and Certifications

• Manufacturing\Six Sigma Green Belt Certification Upon Hire preferred and
• Manufacturing\Lean Six Sigma Black Belt with DOE experience. Upon Hire preferred

Travel Requirements

10%: Up to 26 business days per year

Physical Requirements

Medium-Exerting up to 50lb/22kg of force occasionally and/or up to 20lbs/9kg of force frequently, and/or up to 10lbs/4kgs of force constantly to move objects.

Additional Requirements

• 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.
• Self‑motivated with the ability to make independent and sound judgments.
• Read and interpret data, information, and documents
• Learn and apply new information or skills

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.