Our partner at West, is looking for qualified personnel to fill in the position of a Senior Quality Engineer at Exton, Pennsylvania, US, Quality department,
Requisition ID: 66823
West, is a committed team united by the goal of improving patient lives, which has been at the core of our business for over a century. Our narrative started when Herman O. West resolved the issue of providing the US Government with large amounts of penicillin during World War 2. West’s lasting impact on the healthcare sector is only getting started with our efforts to provide millions of patients with thousands of injectable medications that can save and improve their lives every day. Our story began with a name. What role will yours play in shaping our future?
Job Summary
The Senior Quality Engineer’s duties include providing syringe and drug containment programs with quality direction, governance, and best practices for the Quality Management System. This is a worldwide position that will manage several ongoing projects to guarantee that quality and regulatory compliance is upheld from the beginning of product development to manufacture and maintenance.
This position will guarantee that goods fulfill all design control and relevant regulatory requirements in accordance with the targeted distributed markets, while also achieving quality standards that are consistent with internal procedures and acceptance criteria. In order to assist product development, launch, and post-market surveillance activities, they will collaborate with R&D, Regulatory, Supplier Quality, Analytical Labs, Supply Chain, and Operations.
Essential Duties and Responsibilities
Have a strong “quality first” approach and make sure that the highest standards are met for both process and product quality.
- Project Planning: Oversee the planning process and create detailed plans that include the project’s scope, schedule, budget, resource allocation, and success criteria. Obtain support from the project team and make sure that project planning is inclusive. Determine project success risks proactively, then put mitigation plans in place to lessen their effects.
- Safety and Compliance: In charge of making sure that all applicable safety protocols are followed. In charge of making sure that cGMP guidelines and quality assurance protocols are followed for all pertinent activities.
- Coordination: To guarantee that project goals and success criteria are fulfilled, coordinate project execution with cross-functional teams both inside and outside the laboratory.
- Resource Management: To maximize project results, efficiently manage project finances, scope, resources, and schedules. Determine any gaps or modifications, and make sure resource managers and stakeholders are in agreement with the project’s present requirements.
- Risk management: Oversee the creation and upkeep of hazard and product risk analyses in compliance with West policies and procedures.
- Quality Management System: Lead and manage QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, audit findings, issue reviews, document control, change controls, configuration management, etc.
Basic Qualifications
- A bachelor’s degree in science or engineering is necessary.
- At least six years of expertise in a regulated field, such as medical devices, encompassing post-market surveillance, product development, and manufacturing
- Experience that has been proven (4+ years) independently creating, organizing, and carrying out successful initiatives in highly regulated settings
- In place of a degree, relevant work history and/or experience may be taken into consideration.
Challenges in Ensuring Quality for Integrated Systems
Complexity of Integration
A major problem for quality engineers is the increasing complexity of contemporary systems, which include electronics, software, hardware, and even artificial intelligence (AI). Even minor flaws in one subsystem might escalate into more significant problems as systems get more interconnected, possibly resulting in system-wide failures. The technical expertise of the Senior Quality Engineer is necessary to foresee these problems and create tests that take into consideration how various components interact.
Fast-Paced Technological Advancements
Systems are regularly updated and adjusted due to the quick speed of technology improvements, frequently without enough time for thorough testing. By putting in place testing procedures that are comprehensive and time-efficient, the engineer must strike a balance between the demands of speed and quality.
Compliance with Stringent Regulations
Numerous industries are heavily regulated, including the automotive, medical device, and aerospace sectors. It takes a lot of work and a thorough awareness of both national and international regulatory environments to make sure integrated systems adhere to all applicable standards.
Supplier Management
Another major issue is managing supplier quality, particularly in global supply chains when parts are acquired from several geographical locations. In addition to dealing with potential delays in resolving quality issues in remote locations, the engineer must negotiate variations in production standards and methods.
Importance of the Role in Organizational Success
The organization’s long-term profitability and customer satisfaction are greatly dependent on the Senior Quality Engineer, Integrated Systems. They reduce expensive recalls, warranty claims, and reputational harm by making sure that systems are strong, dependable, and in compliance with rules. Product reliability, a crucial distinction in fiercely competitive industries, is directly impacted by their job.
Additionally, the emphasis on ongoing development keeps businesses at the forefront of innovation. The Senior Quality Engineer aids in cost savings and operational efficiency by promoting process enhancements, lowering faults, and guaranteeing a seamless system integration.
In today’s intricate technical environment, the Senior Quality Engineer, Integrated Systems, plays a crucial and demanding function. These experts make sure that integrated systems, the foundation of many contemporary goods and sectors, run smoothly and provide dependability and excellent performance. Their efforts to manage supplier quality, ensure compliance, and promote continuous improvement have a significant impact on the company’s reputation and financial performance. The role of a Senior Quality Engineer, Integrated Systems is crucial for companies that want to be at the forefront of innovation while upholding the highest standards of quality.