Support the New Product Introduction (NPI) Stage Gate process and other design qualification activities as well as the quality system processes to maintain compliance and effectiveness throughout the entire value stream from supplier through design/manufacturing and to the customer.
Major Responsibilities:
- Utilize the tools of APQP (PPAP, FMEA’s, control plans, capability studies)
- Develop control plans and inspection methods.
- Participate in FMEA activities as the quality representative.
- Participate in design reviews as the quality representative.
- Review and approve design documentation to ensure compliance with the quality system and regulatory requirements.
- Assigned to complex projects and projects for key customers.
- Support customer requests for information, to include regulatory (REACH, RoHS, similar) information; coordinate with Sourcing as necessary.
- Support process qualification activities as assigned.
- Be a safety role model. Engage with employees, supervisors, and management to create and promote a safe work environment.
Salary range: $85,000-$95,000 depending on experience
Qualifications:
Education and Experience:
- Bachelor’s degree required
- 2+ years of experience working with Aerospace and/or Medical Device Quality Management Systems and successfully supporting a Quality function within a low volume, high mix manufacturing environment preferred.
- Knowledge of AS9100D, ISO 9001, or ISO 13485 required.
Successful Essential Skills
- Ethical practice - adheres to the organizations Mission, Vision, Values and Culture. Adheres to policy, procedure and complies with regulatory bodies and the law. Actively positively acknowledges employees demonstrating the right values and works to guide misses of others in the right direction.
- Communication – can clearly and succinctly send a message in a variety of communication settings and styles. Must be able to interact and effectively communicate with individuals at all levels of the organization. Can create open channels of communication, adapt message to fit audience, express ideas clearly and concisely, keep others well-informed, listen carefully to input and feedback.
- Technical Capacity – is a skilled and technically competent compliance professional; a person whose knowledge and skills are respected and sought out.
- Project Management – ability to take a problem statement through a rigorous process and closure, adding value to the organization.
- Able to read and interpret complex engineering drawings and have a good understanding of geometrical dimensioning and tolerance.
- Excellent problem-solving skills uses rigorous logic and methods to solve problems producing effective solutions to problem statements.
- Excellent time management skills: concentrating effort on priorities and overall planning, awareness, and response to what is due now, short, and long term.
- Strong computing skills: i.e., ERP, Customer/Supplier and Regulatory Portals, Power Point, Excel, and technical researching.
- Ability to initiate and complete multiple concurrent projects.
- High level of business acumen: Understands policies, practices, technology, trends, and information and how those affect the business.
We offer a comprehensive benefits package, including Medical/Rx, Dental, Vision, Flexible Spending Accounts, Basic Life/AD&D (includes coverage for dependents 100% Company paid), Short-Term Disability, Long-Term Disability (100% Company paid), Supplemental Life/AD&D, 401(k) with Company match, tuition assistance after 1 year, paid time off, and 11 paid holidays.