Quality Engineer

West Pharmaceutical Services; Williamsport (Lycoming County); On-site; USD 70,000 - 90,000; Full time

Job summary

West Pharmaceutical Services is seeking a Quality Assurance professional in Williamsport, PA. The role involves providing quality support for manufacturing processes and ensuring compliance with ISO standards. Candidates should have a Bachelor’s degree in a technical field and at least 3 years of experience in quality or engineering. Strong statistical skills and familiarity with Minitab are preferred. The position may require up to 10% travel for customer and supplier meetings. Competitive benefits included.

Qualifications

• 3+ years of quality or engineering experience in a manufacturing environment.
• Background in SPC, Root Cause and Corrective Action methods.
• Familiarity with Lean Six Sigma methodologies.

Responsibilities

• Provide quality support for development and validation.
• Conduct audits of various departments as directed.
• Assist in investigating customer complaints.

Skills

Technical support

Communication skills

Problem solving

Statistical analysis

Customer service

Education

Bachelor’s degree in Science, Engineering, or related field

Tools

Minitab

Measuring/testing equipment

SAP

Job description

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, 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 a 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

• Familiar with computers and various software programs.
• Strong knowledge, understanding of statistics and use of Minitab.
• Proficiency with measuring/testing equipment such as calipers, micrometers, comparators, height gauges, vision and data collection systems.
• Excellent communication skills (written & oral), interpersonal, problem solving (root cause failure analysis), planning/organization, negotiation, and computer skills (especially MS Office and statistical analysis systems). General understanding of manufacturing and plant operations is also required.
• Strong customer‑facing experience.
• Background in plastics is preferred.
• Familiarity with SAP, Master Control or similar systems and databases is a plus.
• Ability to follow all relevant standard operating procedures as per company policy.
• Support and contribute to Lean Sigma programs and activities toward delivery of set targets.
• Compliance with the company’s safety policy at all times.
• Compliance with the company’s quality policy at all times.

License and Certifications

• Manufacturing / Six Sigma Green Belt Certification – On‑Hire preferred.
• Manufacturing / Lean Six Sigma Black Belt with DOE experience – On‑Hire preferred.

Travel Requirements

10%: Up to 26 business days per year.

Physical Requirements

Medium exertion: lifting up to 50 lb/22 kg occasionally, 20 lb/9 kg frequently, or 10 lb/4 kg constantly to move objects.

Additional Requirements

• Work well with others in a variety of situations.
• Multi‑task, work under time constraints, solve problems 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.