Overview
Position Summary
The position is responsible to ensure that activities throughout the product lifecycle are in compliance with procedures, standards and regulations applicable to our products. This position provides project level leadership, independently develops, applies, and implements methods, tools and practices to achieve product quality goals and requirements in the areas of design, development, production, distribution, maintenance and service.
This is a technically focused role requiring advanced skills in analyzing information, reviewing technical reports, promoting process improvement, requirements development, risk management, product development and production controls. The position is expected to lead by example in alignment with the company values to achieve objectives.
Responsibilities
Key Accountabilities
Essential Functions:
1. Participates in the generation and review of quality documents throughout the product lifecycle
2. Advises and directs teams regarding compliance to procedures, standards and regulations
3. Ensures product quality meets requirements and documentation is complete prior to approval
4. Participates on core teams supporting new product development or design changes.
5. Defends relevant quality topics in audits and corrective actions to improve and maintain compliance of the QMS
6. Interprets regulations and procedures to ensure documents are sound and defensible to auditors and regulatory bodies.
7. On projects of significant scope, leads successful implementation of Design Control and Product Realization requirements for design, production and distribution of IL products
8. On new product development and or product performance investigations, provides guidance on most appropriate tools and techniques available
9. Provides input on product requirements, acceptance criteria, traceability, process monitoring, product evaluation, failure investigation and complaint analysis.
10. Ensures 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 IL products.
11. Provides guidance on compliance of software to procedures and standards including cyber security and privacy requirements
12. Works with manufacturing, R&D, Service, Distribution, Sales & Marketing, and others outside the company (as needed) to recommend or prepare corrective/ preventive actions (CAPA).
13. Reviews and approves change orders for product performance, process changes, labeling and marketing communications as required.
14. May manage and supervise the work of others
15. Leads cross-functional projects on technical and quality issues
16. Other duties as assigned
Secondary Functions:
17. Identifies compliance gaps and takes appropriate corrective actions as needed
18. Defends documents and procedures internal and external audits
19. Leads quality system improvement projects as required.
Budget Managed (if applicable)
20. N/A
Internal Networking/Key Relationships
To be determined based on department needs, to include interactions such as:
21. Works closely with other functions to generate compliant documents by interpreting and explaining quality procedures, applicable standards, regulations and best practices.
22. Able to effectively communicate quality requirements to a broad population of constituents.
23. Ability to negotiate and influence others in establishing direction toward improved quality and enhanced compliance.
Skills & Capabilities:
The ideal candidate for this position will exhibit the following skills and capabilities:
24. Working knowledge of domestic and international quality/regulatory standards related to our products
25. Knowledge of quality management techniques (Lean, Six Sigma) and statistical techniques required to measure and confirm significant changes.
26. Working knowledge of IL products, technology and manufacturing processes including impact on customers and patient requirements.
27. Demonstrates judgement commensurate with experience regarding application of regulatory requirements to data review, reports, design changes, risk management, to ensure compliance and achieving business objectives.
28. Demonstrated understanding of risk based approach to processes and decisions.
Competencies:
29. Attention to Detail: Ability to pay close attention to detail is required
30. Accuracy: Work is accurate and complete
31. Performance Standards: Demonstrated ability to meet department goals
32. Communication: Excellent written, verbal and presentation skills
33. Discretion: Acts with integrity in all situations and can maintain appropriate confidentiality
34. Multi-Tasking: Ability to manage multiple priorities, and support changing business needs
35. Collaboration: Ability to work within a multi-function team to bring best solutions to the team or customer
36. Independence: Self-motivated-works under minimal supervision
37. Professionalism: Must demonstrate professionalism during all interactions within company, customer and third parties
38. Takes Initiative: Serves as a role model for "Quality First" by continuously improving on what matters most to customer.
39. Problem Solving: Promptly and effectively handles issues and problems
40. Decision Making: Makes decisions based on data and risk determination
Qualifications
Minimum Knowledge & Experience required for the position:
Education: Bachelor's degree or equivalent in engineering or science
Experience: A minimum of 10 years of experience in medical devices,
pharmaceuticals, diagnostic industry, or clinical laboratory or 7 years of experience
with an advanced degree.
Additional Skills/Knowledge:
41. Duties necessitate broad and thorough knowledge of engineering and science theory and principles, including R&D, quality control, manufacturing and design engineering
42. Understanding of the application of technical principles and engineering problem solving to resolve complex issues.
43. ASQ Quality Engineering Certification - Desirable
44. LEAN/Six Sigma Certification - Desirable
45. Language: English
International Mobility:
46. Required: No
Travel Requirements:
47. Approximately 10% of time
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