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- Tasks: Analyse changes and resolve issues while collaborating with cross-functional teams.
- Company: Leading medical device company focused on quality and innovation.
- Benefits: Competitive hourly pay, professional development, and a dynamic work environment.
- Why this job: Join a team that drives improvements in medical device quality and compliance.
- Qualifications: Bachelor's degree and 5-7 years in quality or manufacturing in the medical device industry.
- Other info: Opportunity to lead projects and make impactful decisions in a fast-paced setting.
The predicted salary is between 40 - 45 £ per hour.
Pay Range: $51.90hr – $56.90hr
Responsibilities:
- Analyze varying complexity of changes and resolve issues with collaboration from cross-functional departments.
- Understand Product Lifecycle Management, ERP, and other Change Control processes and relationships.
- Able to multi-task and handle variable loads independently within multiple systems (Windchill PLM, JDE).
- High attention to detail and robust understanding of document control and GDP.
- Proactive, quick learner with strong communication and decision-making skills.
- Support and process change packages against governing procedures, interact with departments to complete the change package, and release final change package.
- Perform incorporation of approved changes to documentation (e.g., JDE data entry and verify correct implementation).
- Participate in special projects, complete assigned tasks, and deliverables.
- Evaluate changes proposed by initiators and provide feedback.
- Other incidental duties assigned by Leadership.
- Work independently without close supervision.
- Compare and evaluate possible courses of action after considering various possibilities.
- Apply knowledge in following procedures or in determining which procedures to follow or determining whether specified standards are met.
- Consider the cause and effect of activities.
- Determine or effectively recommend course of action after considering potential risks of alternatives.
- May provide guidance to lower-level personnel.
- Make decisions in the face of different alternatives and without formulas or guidelines, or with guidelines that are not complete and exhaustive, allowing room for creativity and judgment.
- Direction tends to be high-level and focused on end results, with means of accomplishment left to the incumbent.
- Lead small-scale projects where analysis of situations requires an in-depth evaluation of multiple factors and/or requires an in-depth knowledge of organizational objectives.
- Drive to resolve these issues completely and with speed by leveraging your network of key contacts outside your own area of expertise.
- Drive improvement of current practices and work with the appropriate functions to implement changes or participate in their implementation.
Additional Skills:
- Experience in a quality and/or manufacturing environment in the medical device industry is required.
- Proven expertise in MS Office Suite.
- Knowledge of Windchill PLM preferred.
- Excellent written and verbal communication skills, including negotiating and relationship management skills.
- Strong problem-solving and critical thinking skills.
- Good understanding of medical device documentation development activities.
- Ability to manage confidential information with discretion.
- Strict attention to detail.
- Ability to interact professionally with all organizational levels.
- Ability to manage competing priorities in a fast-paced environment.
- Adhere to compliance with internal procedures.
Education and Experience:
- Bachelor's Degree or equivalent in a related field of study.
- Experience in a quality and/or manufacturing environment in the medical device industry is required.
- 5-7 years of experience required.
Senior Quality Systems Analyst in Irvine employer: Cynet systems Inc
Contact Detail:
Cynet systems Inc Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Quality Systems Analyst in Irvine
✨Network Like a Pro
Get out there and connect with folks in the industry! Attend events, join online forums, or even hit up LinkedIn. The more people you know, the better your chances of landing that Senior Quality Systems Analyst gig.
✨Show Off Your Skills
When you get the chance to chat with potential employers, make sure to highlight your experience with PLM systems like Windchill and your knack for problem-solving. We want them to see how you can tackle those complex changes and drive improvements!
✨Prepare for the Interview
Do your homework on the company and the role. Be ready to discuss how your background in quality and manufacturing aligns with their needs. We want you to walk in confident and ready to impress!
✨Apply Through Our Website
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who are proactive about their job search!
We think you need these skills to ace Senior Quality Systems Analyst in Irvine
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Senior Quality Systems Analyst role. Highlight your experience in quality and manufacturing, especially in the medical device industry, and showcase how your skills align with the job description.
Showcase Your Attention to Detail: Since this role requires a high attention to detail, be sure to proofread your application thoroughly. Any typos or errors could give the impression that you don’t pay close attention, which is crucial for this position.
Demonstrate Your Problem-Solving Skills: Use specific examples in your application to illustrate your problem-solving and critical thinking abilities. This will help us see how you approach challenges and make decisions, which is key for the role.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands and shows your enthusiasm for joining our team at StudySmarter!
How to prepare for a job interview at Cynet systems Inc
✨Know Your Stuff
Make sure you brush up on your knowledge of Product Lifecycle Management, ERP, and Change Control processes. Familiarise yourself with Windchill PLM and JDE, as these are crucial for the role. Being able to discuss these systems confidently will show that you're prepared and serious about the position.
✨Showcase Your Problem-Solving Skills
Prepare examples from your past experience where you've successfully resolved complex issues or improved processes. Highlight your critical thinking and decision-making abilities, especially in situations where you had to weigh different options without clear guidelines. This will demonstrate your capability to handle the responsibilities of the role.
✨Communicate Effectively
Since strong communication skills are essential, practice articulating your thoughts clearly and concisely. Be ready to discuss how you've managed relationships and negotiated outcomes in previous roles. Remember, it's not just about what you say, but how you say it!
✨Be Proactive and Engaged
During the interview, show your enthusiasm for the role by asking insightful questions about the company’s current projects and challenges. This will not only demonstrate your interest but also your proactive nature, which is key for a Senior Quality Systems Analyst. Plus, it gives you a chance to assess if the company aligns with your career goals.
