Are you an innovative Quality Assurance driver with a passion for the Medical Device industry? Do you thrive in team environments, supporting product quality improvements, and quality system compliance? Do you enjoy product risk management and test method development?
If your answer is yes, then we may be looking for you!
Spectranetics, recently named “Most Trusted Companies”, has an opening for a Design Assurance Technician II.
What You Will Do: You will serve as a Design Assurance team member on all objectives related to specific identified business opportunities. You will be afforded the opportunity to use your expertise to lead and ensure relevant functional activities on a project team are completed to ensure successful and reliable new product development.
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, Clinicians, Sales Leaders, and other industry professionals about our state of the art products.
What You Will Become: A highly influential teammate who will be key in supporting product development and execution for high impact results helping achieve our mission of delivering consistently high quality, safe and effective, regulatory compliant products and services.
What Success Looks Like:
Quality System Compliance
Possess a basic knowledge of Design Controls as defined in 21 CFR, Part 820 and ISO 13485 (210 & 211 desirable).
Assist in creation and monitoring of training activities.
Assist in creation and maintaining product Design History File – DHF
Assist in monitoring and tracking of calibration and maintenance activities.
Basic understanding of statistical analysis as it pertains to sample sizes.
Quality Control Data Review
Possess a basic knowledge or aptitude for Analytical Chemistry methods
Participate in the review of laboratory outputs relating to analytical chemistry.
Assist in investigation of customer complaints and product analysis as a part of complaint handling
AS Degree in a Technical field preferred
Combination Product Experience highly desired
2 to 5 years' experience in the medical device industry
Knowledge of Database software; Manufacturing software; Spreadsheet software and Word Processing software.
Ability to multitask and prioritize work assignments is required.
Candidate needs to work well cross functional within the product development team.
Strong verbal and written communication skills.
Using basic measurement equipment and working in a lab environment.
Strong computer skills and proficiency with MS Excel and Word.
Minitab data analysis experience is highly desired.
Experience in design assurance, quality or product development is highly desired.
Material and Equipment Directly Used:
Spectranetics' Policies and Procedures
FDA regulations and international standards
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 position announcement 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 posting 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.
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