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Sr Quality Engineer
200 Medtronic Drive Lafayette, CO 80026 US
Job Description
50-65/h depending on experience
**This posting replaces 607693, HM was not getting the right skillset/exp so changed it to a Sr QE role, must haves below. New candidates only HM not interested in anyone submitted to the Sr Mech Design Engineer role.
These are the Must Have’s:
- Product Part Approval Process Experience
- Advanced Understanding of IQ, OQ, PQ
- Molding Experience
- Understanding of GD&T
- Experience using statistical techniques like process capability
Education Required: Bachelor’s Degree in Engineering
Years’ Experience Required: Minimum of 4 years of relevant experience
Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hours per week
Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Hybrid, 3 days on site minimum
What is your timeline for scheduling interviews? ASAP
What product line will this person support? LigaSure™ and Sonicision™ products under Advanced Surgical Technologies
Sr. Supplier Quality Engineer
Careers that Change Lives
Help streamline and speed our time to market and build quality in at every step. You will be a member of the Released Product Engineering team that supports the design, development, and maintenance of innovative, new medical device products, as well as commercially released products within the Advanced Surgical Technologies business. You can apply advanced technical concepts to complex problems throughout the product life cycle.
In this role, you will work as part of a team, providing technical support on New Product Development and Sustaining Project Initiatives, ensuring medical devices are designed with the utmost regards to safety, reliability and quality. You will be responsible for reviewing supplier documentation including First Article Inspection Reports and OQ/PQ documentation and assisting with new component supplier qualifications with help from the Released Product Engineering team.
A Day in the Life
- Ensures that suppliers deliver quality parts, materials, and services.
- Qualifies suppliers according to company standards
- Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
- Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
- Provides technical guidance and quality compliance for Supplier Quality engagement throughout the lifecycle on newly qualified parts and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements.
- Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy and Control Plans for new components.
Must Haves:
- Bachelor’s degree and a minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience.
- Product Part Approval Process Experience
- Understanding of IQ, OQ, PQ
- Molding Experience
- Understanding of GD&T
Nice to Have
- Degree in Engineering or Scientific discipline
- CAD Experience
- Detail-oriented with strong commitment to quality and to the workplace.
- Excellent analytical, organizational, and communication skills. Strong ability to work with multidisciplinary and global teams.
- High tolerance for change, and ability to multi-task continuously.
- Strong negotiation, conflict management, and influence management skills.
- Experience in the medical device industry.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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