West Pharma Sr Principal Quality Engineer 

United States, Arizona, Scottsdale 

775168092

Job Summary:

Maintain a safe work environment and ensure compliance with quality objectives and policies. Work with business leads to develop, implement, and maintain programs and enhance solutions for customer base. Provide quality assurance support to all functions with focus on compliance in accordance with ISO 13485, ISO 14791, 21 CFR 820, and 2017/745 (EU/MDR) requirements. This role will support the execution of high complexity/impact projects that will impact the Quality of the product and a Compliance improvement significantly throughout the implementation of changes involving supplier related items, validation process, Quality Culture, risk management process improvement, change management, material controls improvement and Quality Control items.

Essential Duties and Responsibilities:

• Interface with internal constituents and external regulatory bodies regarding compliance needs asrequired
• Assist in the preparation of the Management Review meeting presentations on a quarterly basis.
• Attend project team meetings on a regular basis and provide assistance with validation and regulatory strategies for various projects.
• May review and approve Complaint, CAPA, Audit Findings, Issue Reviews, Non-conformances investigations to provide guidance to ensure effective investigations are completed.
• Prepare Validation Strategies and executes accordingly by writing technical reports as needed.
• May create and execute validation protocols such as IQs, OQs, PQs, and/or TMVs.
• Supports the site with statistical techniques guidance to ensure compliance at the different departments during design transfer process, sampling plan implementations or improvements, establishments of CTQs, Validation strategies, and investigations as required.
• Provide continued quality system support by improving processes and systems and by updating andcreating site procedures or enterprise procedures, Inspection requirements, Test Method inspections, etc.
• Participate in third party (Notified Body, FDA, Customer) audits as required: Back room lead, SME, Reviewer, etc.
• May manage key quality system programs such as CAPA, Quality Culture initiatives, Non-conformance or other QMS elements programs that are to be monitored and under control.
• Provide support to manufacturing lines to address issues and escalate issues to NC or CAPA process as needed.
• May work with high-risk investigation to document Quality Issues resolutions involved with internal issues or customer and external regulatory bodies through CAPA, SCAR, NCR, Issue Review, External Audit findings (Regulatory bodies: FDA, DEKRA, SGS) to ensure proper and robust actions are taken to eliminate re-occurrence.
• May supervise exempt and non-exempt personnel as required.
• Provide guidance, coaching, and train other Quality Engineers in Engineering topics such as Validation process, Root Cause Analysis, Statistical techniques, SPC, CAPA, NCRs, etc.
• Escalate Quality issues to upper management based on risk, trend, and compliance assessment.
• Ensure Site Metrics are complying with internal requirements and goals established.
• Work with high-complexity projects to ensure a process continuous improvement is in place.
• Create high-complexity Projects strategies and ensures execution is completed in a timely manner.
• Drives activities to reinforce Quality Culture through Quality initiatives, or processes related.
• May provide coaching to engineers/auditors to promote people development and process improvement culture.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.

• Exhibits regular, reliable, punctual, and predictable attendance .

• Contributes to continuous process improvement efforts to reduce scrap, cycle times, improve efficiency, quality culture reinforcement, and eliminate waste.
• Provides a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Maintains a clean, orderly, and safe workstation and environment always.
• Performs other duties as assigned based on business needs.

Basic Qualifications:

• Education or Equivalent Experience: Engineering Bachelor’s Degree or equivalent
• Experience: 8-10yrs Quality Engineering Experience
• Validation Process knowledge
• Medical Device Regulations and standards (ISO 13485, ISO 14791, 21 CFR 820, and 2017/745 (EU/MDR)
• Project Management

Preferred Knowledge, Skills, and Abilities:

• Supervision skills
• Excellent communication ability
• Strong problem-solving skills, Six Sigma a plus
• Demonstrate understanding of QC and/or Six Sigma skills such as Control, Run, and Pareto Charts, Histogram, Scatter Plot, Gantt chart, Fishbone Analysis and Process Capability.
• Root Cause Analysis proficient.
• 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 always comply with the company’s safety policy.
• Able to always comply with the company’s quality policy.
• CQA Certification is preferred.
• CQE Certification is preferred.
• Green Belt/Black Belt Certification is preferred.
• Lead Auditor Certification preferred.

Travel Requirements:

Physical and Mental Requirements:

• Medical Device manufacturing requires strict adherence to standards. Working environment is a manufacturing facility, which houses plastic injection molding machines. Must tolerate fumes and particulate generated from various plastics. Work areas are equipped with adequate lighting, cooling/heating and equipment that are in a good working condition. Must work constructively in an environment that may be stressful due to competing resources while at all times maintaining company confidentiality.
• May stand or sit for extended periods of time. Must transport oneself to and from other areas of the facility and travel to other divisions when necessary. Must have good visual acuity. If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues. Hearing ability should be sufficient to hear audible alarms from distances up to 150ft.
• The ability to be able to lift and carry various items up to 50lbs. 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