Overview
Position Summary:
The position is an entry level position responsible to ensure that activities throughout the product lifecycle are complaint with procedures, standards, and regulations applicable to our products. This position, with direct guidance from manager or more senior staff, will work to achieve product quality goals and quality requirements in the areas of design, development, production, distribution, maintenance, and service.
This is a technically focused role requiring skills in analyzing information, reviewing technical reports, promoting process improvement, requirements development, risk management, product development and production controls.
Responsibilities
Key Accountabilities
Essential Functions:
1. Participates in the generation and review of quality documents throughout the product lifecycle
2. Ensures product quality meets requirements and documentation is complete prior to approval
3. Participates on core teams supporting new product development or design changes
4. On new product development and or product performance investigations, provides guidance on tools and techniques available
5. Provides input on product requirements, acceptance criteria, traceability, process monitoring, product evaluation, failure investigation and complaint analysis.
6. Advises regarding application of sound statistical methods and quality tools in the evaluation and documentation of results related to design control, purchased part qualifications, V&V, risk analysis, production transfer, production, distribution, and marketing of Werfen products.
7. Provides guidance on compliance of software to procedures and standards including cyber security and privacy requirements
8. Reviews and approves change orders for product performance, process changes, labeling and marketing communications as required.
9. Other duties as assigned
Secondary Functions:
10. Participates in quality system improvement projects as required.
Budget Managed (if applicable):
11. N/A
Internal Networking/Key Relationships:
To be determined based on department needs, to include interactions such as:
12. Works closely with other functions to generate compliant documents in alignment with quality procedures, applicable standards, regulations, and best practices.
13. Ability to negotiate and influence others in establishing direction toward improved quality and enhanced compliance.
Skills & Capabilities:
The incumbent in this position will exhibit the following skills and capabilities:
14. Ability to read and interpret domestic and international quality/regulatory standards related to our products
15. Demonstrates judgement commensurate with experience regarding application of regulatory requirements to data review, reports, design changes, risk management, etc. to ensure compliance and achieving business objectives. Demonstrated understanding of risk-based approach to processes and decisions.
16. Recognition of when to escalate issues to management or consult with more senior staff members.
17. Ability and willingness to learn about products, processes and procedures relevant to role
Competencies:
18. Attention to Detail: Ability to pay close attention to detail is required
19. Accuracy: Work is accurate and complete
20. Performance Standards: Demonstrated ability to meet department goals
21. Communication: Excellent written, verbal and presentation skills
22. Discretion: Acts with integrity in all situations and can maintain appropriate confidentiality
23. Multi-Tasking: Ability to manage multiple priorities, and support changing business needs
24. Collaboration: Ability to work within a team to bring best solutions to the team or customer
25. Independence: self-motivated-works under minimal supervision
26. Professionalism: Must demonstrate professionalism during all interactions within company, customer and third parties
27. Takes Initiative: Serves as a role model for “Quality First” by continuously improving on what matters most to customers
28. Problem Solving: Promptly and effectively handles issues and problems
29. Decision making: Makes decisions based on data and risk determination
Qualifications
Minimum Knowledge & Experience Required for the Position:
Education:
30. Bachelor's degree or higher in engineering or science
Experience:
31. A minimum of 1 years of experience in a technical field or 0 years of experience with advanced degree
Additional Skills/Knowledge:
32. Duties necessitate basic knowledge of engineering and science theory and principles, including R&D, quality control, manufacturing, and design engineering.
33. Understanding of the application of technical principles and engineering problem solving to resolve complex issues.
34. Language: English
International Mobility:
35. Required: No
Travel Requirements:
36. Approximately 10% of time
The annual base salary range for this role is currently $65K to $80K. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.
This role is eligible for medical, dental, and vision insurance, k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.
If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.
Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact for assistance.
We operate directly in over 30 countries, and in more than territories through distributors. Annual revenue is approximately $2 billion and more than 7, employees around the world comprise our Werfen