Are you looking for an opportunity to apply your technical skills to process review, approval, audits and quality systems? Do you have a drive to contribute, learn, and be an integral member of a high-performance Quality team?
If your answer is yes, then we may be looking for you! Spectranetics has an opening for a Quality Specialist.
What You Will Do: Working under the oversight of experienced Quality leadership, you will be a contributing member of our Quality team. Your tasks will include reviewing documents for accuracy, completeness and verification to company specifications.
What You Will Learn: Spectranetics attracts and hires the best talent on the planet! You will be working with a great team of dedicated experts and leaders in the Medical Device Industry who will support your continued growth. You will learn from our Engineers, Manufacturing, Materials and other industry professionals about all facets of our state of the art medical device growth company.
What You Will Become: A highly technical teammate with an expert understanding of Quality System needs and experience interfacing with teammates and other departments to meet those needs.
What Success Looks Like:
- Review documentation for accuracy, completeness and to verify that product meets specification at incoming, in-process or finished goods.
- Review Lot History Records for completeness, accuracy and compliance.
- Perform quality reviews of documentation and records review.
- Notify supervisor if/when a non-conformance is observed and assist in segregating non-conforming material as required.
Material and Equipment Directly Used:
- Computers with applicable software packages (e.g. SolidWorks, Minitab, Microsoft Office, Microsoft Project, Microsoft Power Point, etc.)
- Experience in the Medical Device and/or Pharmaceutical industry with at least 3 years in Quality function, preferred
- Solid technical understanding of quality systems.
- Ability to read and understand SOP's and related documents
- Ability to effectively and professionally communicate.
- Demonstrated communications skills to enable effective contribution as a member of a multi-functional team is essential
- Working knowledge of regulatory requirements
- Quality Audit training preferred
Agencies that submit a resume to SPNC must have a current executed SPNC Agency Agreement executed by a member of the Talent Acquisitions Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a SPNC Recruiter. All resumes must be submitted to the vendor portal under these terms or they will not be considered.
This job description is intended to describe the general nature and level of work assigned to individual filling this position. This is not intended to be an exhaustive list of all responsibilities, duties or skills required. This job description is subject to change as the needs and requirements of the department and business change.
All applicants must pass a pre-employment drug screen to be hired.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or status as an individual with a disability.