Quality Systems Analyst II

About us

At Plexus, our vision is to help create the products that build a better world.  By embracing an innovative culture of excellence, we pride ourselves on designing, manufacturing and servicing some of the world’s most transformative products. From life-saving medical technology and mission-critical defense solutions to sophisticated industrial automation, we’re proud to partner with our customers to bring their complex ideas to market. 

Visit Plexus.com to learn more about our unwavering commitment to our vision. 

Living Our Values

With a vision rooted in the wellbeing and inclusive engagement of our team members, our customers, their end users and our communities, people are the heart of what we do and who we are. Our values unite and guide us in everything that we do. 

Our values include: Growing our People, Building Belonging, Innovating Responsibly, Delivering Excellence and Creating Customer Success. 

As part of our team, you’ll do impactful work within an inclusive environment where everyone works together to achieve extraordinary outcomes. You’ll be empowered to reach your full potential through managing your own personalised development plan and access to our learning and development programs.

Purpose Statement:  Aid in ensuring compliance and continual improvement activities for the Plexus Quality Management Systems.

Key Job Accountabilities:

• Lead, manage and/or participate in internal and external audits for applicable market sectors including customer audits/visits, regulatory inspections and registrar/certification audits as requested. This may include creating and maintaining the internal audit schedule.
• Manage, support or coordinate Corrective and Preventive actions to ensure timely response, follow through, and appropriate reporting to management.
• Work on special projects as requested to improve the quality management system, which may include assisting with process validations, or documentation such as assembly build instructions, device travelers, certificates of compliance, complaint files, DMRs, DHRs, etc.
• Assist to establish regulatory guidelines and industrial standards in quality system and work with site quality managers to ensure compliance at sites/region.
  Remain abreast of new and ever-changing applicable quality system standards and regulatory requirements.
  Relevant standards may include ISO 9001, ISO 13485, AS 9100, Nadcap, ISO 14001, etc.
• Supports the design and installation of the quality system.
  Assists to communicate quality system and regulatory requirements with internal customers.

Education/Experience Qualifications:

• Bachelor’s Degree with 2 or more years of related experience is preferred. An equivalent combination of education and/or experience will be considered.

Other Qualifications:  

• Employee must be self-motivated with the ability to work independently and in a team environment.
• Good oral and written communication skills are necessary.
• Attention to detail, good problem solving skills, and computer literacy are essential.
• Project management and knowledge of ISO 9001, ISO 13485 and AS9100 a benefit, but not required.

Physical Requirements:  

• Professional office environment with suitable lighting, comfortable temperatures, and low noise level. May require prolonged periods of sitting at a desk, using a computer, and other office equipment. Minimal physical activity is generally involved, emphasizing the importance of good posture and ergonomic workplace arrangements.

Travel Requirements:  

• Less than 40%

This document does not represent a contract of employment and is not intended to capture every possible assignment the incumbent could be asked to perform.

Your Rewards and Wellbeing

We believe in rewarding your contribution with a comprehensive package designed to support your life both inside and outside of work. 

Financial Bonuses & Compensation: 

• 13th Salary
• Meal Tickets
• Childbirth Bonus
• Financial Support for Exceptional Situations
• Referral Bonus
• Discretionary Performance-Related Bonus

Health & Wellbeing:

• Private Health Insurance
• Psychotherapy & Emotional Support
• Fitness Membership in Oradea
• On-site Medical Cabinet

Annual Leave & Time Off:

• Annual Leave: Employees receive between 22 and 26 days of paid annual leave, scaling with their seniority
• Volunteer Time Off

Recognition & Rewards

• Employee Recognition Program
• Idea Generation Program
• "Thank You" Program

Everyday Perks & Facilities

• Free Transportation
• On-site Canteen
• Bookster
• Employee Discounts

Application Process

At Plexus, we don't look for culture fit, we look for culture add. We value the unique perspectives you bring and review every candidate holistically, balancing professional experience, education and individual journey. 

Accessibility and Accommodations

As a Disability Confident employer, we recruit purely on the basis of skills and merit, ensuring an equitable process for everyone. We are committed to providing reasonable accommodations for individuals with disabilities or special requirements. If you require support during the application process, please contact us at [email protected] with your contact information and a description of your needs.

Note: This inbox is dedicated to accommodation requests; please note that application status updates cannot be provided via this address.