Sr Principal Quality Engineer
10 hours ago
Requisition ID: 66167 Date: Nov 12, 2024 Location: Scottsdale, Arizona, US Department: Quality 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: 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: None 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 #LI-KR1 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. Sr Principal Quality Engineer
-
Sr Principal Quality Engineer
4 months ago
Scottsdale, United States West Pharmaceutical Services Full timeJob 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...
-
Principal Engineer
7 days ago
Scottsdale, Arizona, United States TEC Group Inc. Full timeOverviewTec Group Inc. is a renowned organization dedicated to delivering exceptional engineering services. We are currently seeking a highly skilled Principal Engineer - Site Development to join our team in Scottsdale.The ideal candidate will have extensive experience with CAD standards and advanced Civil 3D skills to develop, modify, and review complex...
-
Sr Data Engineer
1 week ago
Scottsdale, United States VDart Full timeRole: Sr Data Engineer Location: Scottsdale, AZ Duration: 9 Months Contract Type: Onsite Must Have Skills: Strong Proficiency in Python (Programming Language), Apache Airflow and Google Cloud Data Services. Must Have Skills: 7+ years' experience in python programming experience in complex data structures as well as data pipeline development. Must Have...
-
Sr. ASIC/FPGA Verification Engineer
4 weeks ago
Scottsdale, United States Softworld Inc Full timeJob Title: 80570 - Sr. ASIC/FPGA Verification EngineerJob Location: Scottsdale AZ 85257Onsite Requirements:UVMSystem VerilogUS CitizenJob Description
-
Sr. Advanced Systems Engineer
5 days ago
Scottsdale, United States GeoLogics Consulting Full timePosition: Sr. Advanced Systems Engineer (Contract)Location: ONSITE in Scottsdale, AZPay: Up to $87.20 per hourClearance Requirement: The ability to obtain a DoD issued Secret clearance is required. An Active Secret clearance is preferred. Applicants selected will be subject to a U.S. Government security investigation and must meet eligibility...
-
Sr Systems Engineer
3 days ago
Scottsdale, United States Softworld Inc Full timeJob Title: 81067 - Sr Systems EngineerCheck you match the skill requirements for this role, as well as associated experience, then apply with your CV below.Job Location: Scottsdale AZ Onsite Requirements:SpatchcockSystems requirements managementSystem integratioJob Description: As a systems engineer for the SDA GMI program, you'll be a member of a cross...
-
Quality Engineer
1 week ago
Scottsdale, United States Innovative Health LLC Full timeThe Quality Engineer will ensure compliance to required standards including FDA and ISO during process development and the manufacturing of medical device components. In addition, this person will have responsibility for identifying and driving improvements related to quality, compliance to regulatory requirements and business efficiencies within the Quality...
-
SDA GMI Network Engineer
6 months ago
Scottsdale, United States General Dynamics Full timeBasic Qualifications Requires a Bachelor’s degree in Systems Engineering, or a related Science, Engineering or Mathematics field. Also requires 10+ years of job-related experience, or a Master's degree plus 8 years of job-related experience. Agile experience preferred. CLEARANCE REQUIREMENTS: Department of Defense Secret security clearance...
-
Principal Architectural Project Manager
3 days ago
Scottsdale, Arizona, United States SPS+ Architects Full timeServing clients and communities across Arizona and beyond, SPS+ Architects specializes in K-12 education while also bringing expertise to various other sectors.Our commitment to understanding our clients' needs drives us to uncover possibilities and design purposeful spaces that serve for generations.We are seeking a Principal Architectural Project Manager...
-
Sr. Mechanical Engineer
1 week ago
Scottsdale, United States West Pharmaceutical Services Full timeSr. Mechanical Engineer (Structural and Fluid Analysis) Requisition ID: 66660 Date: Nov 25, 2024 Location: Scottsdale, Arizona, US Department: R&D Description: This is a hybrid role (3 days onsite). Candidates applying must be within a 50 mile radius of either Exton, PA or Scottsdale, AZ. Who We Are: At West, we’re a dedicated team that is...
-
Sr. Engineer, Complaints/Product Analysis
1 week ago
Scottsdale, United States West Pharmaceutical Services Full timeSr. Engineer, Complaints/Product Analysis Requisition ID: 67773 Date: Nov 30, 2024 Location: Scottsdale, Arizona, US Department: Quality 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...
-
Sr QA Test Engineer
1 week ago
Scottsdale, United States Republic Services Full timePOSITION SUMMARY: The Senior QA Test Engineer is responsible for leading the end to end quality of projects within the Company’s Web, Mobile, and other Application Portfolios. The Senior QA Test Engineer is responsible for architecting new automated test strategies and frameworks in addition to creating, testing, and planning for both manual and automated...
-
Sr. Software Engineer
7 days ago
Scottsdale, United States Encora Full timeJob Summary: The Senior Software Engineer will be responsible for setting technical direction for cloud adoption and maintaining constantly changing architectures of existing on prem apps. This individual must be able to define best practices for complex solutions and develop migration of existing on-premise applications to cloud architectures. This...
-
Sr. Software Engineer
5 days ago
Scottsdale, United States Encora Full timeJob Summary: The Senior Software Engineer will be responsible for setting technical direction for cloud adoption and maintaining constantly changing architectures of existing on prem apps. This individual must be able to define best practices for complex solutions and develop migration of existing on-premise applications to cloud architectures. This...
-
Quality Systems Engineer
7 days ago
Scottsdale, United States Innovative Health LLC Full timeThe Quality Systems Engineer role is responsible for supporting all areas of the pre-and post-market quality system activities; ensuring that the Quality System complies with FDA, ISO and customer requirements. Essential Duties and Responsibilities: Employ quality assurance methodologies in support of quality, engineering, manufacturing and regulatory...
-
Sr. IT Project Manager
7 days ago
Scottsdale, United States Irvine Technology Full timePosition: Sr. IT Project Manager Location: Scottsdale, AZ (Hybrid Model, 3 Onsite / 2 Remote) Work Model: Onsite Tuesday, Wednesday and Thursday - flexible / Remote Monday and Friday Duration: 6+ month contract, will go longer Hourly Rate: 50/hr to 59/hr (W2 or Corp to Corp) Industry: Hospitality Experience Overview: Software Development side of the...
-
Sr. IT Project Manager
7 days ago
Scottsdale, United States Irvine Technology Full timePosition: Sr. IT Project Manager Location: Scottsdale, AZ (Hybrid Model, 3 Onsite / 2 Remote) Work Model: Onsite Tuesday, Wednesday and Thursday - flexible / Remote Monday and Friday Duration: 6+ month contract, will go longer Hourly Rate: 50/hr to 59/hr (W2 or Corp to Corp) Industry: Hospitality Experience Overview: Software Development side of the...
-
Sr. IT Project Manager
7 days ago
Scottsdale, United States Irvine Technology Full timePosition: Sr. IT Project ManagerLocation: Scottsdale, AZ (Hybrid Model, 3 Onsite / 2 Remote)Work Model: Onsite Tuesday, Wednesday and Thursday - flexible / Remote Monday and FridayDuration: 6+ month contract, will go longerHourly Rate: 45/hr to 52/hr (W2 or Corp to Corp)Industry: HospitalityExperience Overview: Software Development side of the business...
-
Sr. IT Project Manager
2 weeks ago
Scottsdale, United States Irvine Technology Corporation Full timePosition: Sr. IT Project ManagerLocation: Scottsdale, AZ (Hybrid Model, 3 Onsite / 2 Remote)Work Model: Onsite Tuesday, Wednesday and Thursday - flexible / Remote Monday and FridayDuration: 6+ month contract, will go longerHourly Rate: 45/hr to 52/hr (W2 or Corp to Corp)Industry: HospitalityExperience Overview: Software Development side of the business...
-
Accounting Analyst Sr.
1 week ago
Scottsdale, United States LHH Recruitment Solutions Full timeJob DescriptionJob DescriptionAccounting Analyst Senior Needed! (Accounts Payable)LHH has a client in Scottsdale, AZ who needs an Accounting Analyst Sr. on a contract opportunity! This is a great chance to get in with a reputable company to advance your career. (Chance to extend based on business need)Job Overview:Performs a variety of routine and some...