Are you a driven program manager and innovative Quality Systems leader with a passion for the Medical Device industry? Do you thrive in managing large scale projects and driving compliance and performance improvements? Do you enjoy managing change initiatives, and establishing systems to support a team?
If your answer is yes, then we may be looking for you!
Spectranetics, recently named one of the “Most Trusted Companies” has an opening for a Continuous Improvement Leader.
What You Will Do: You will serve as the strategic leader on all objectives related to driving compliance and continuous improvement across the entire Quality System. You will be afforded the opportunity to use your expertise to develop, implement and manage systems and methods for identifying, correcting and preventing internal quality issues; provide a variety of Quality services to all company functions which ensure compliance with regulatory agencies; and lead continuous improvement.
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 leader who will be key in shaping strategy and driving execution for high impact results helping drive our mission of delivering consistently high quality, safe and effective, regulatory compliant products and services.
What Success Looks Like:
Large scale program management experience leading multiple workstreams requiring significant cross-functional involvement
Developing and managing program plans including: schedules, resourcing, budgeting, and communication with leadership
Proactively evaluating the workstreams for opportunities to improve performance at a program level and continuously monitoring risk, and mitigating as appropriate
Providing daily direction and guidance to workstream leaders in the execution of the project
Escalation of cross-functional support issues to leadership as appropriate
Providing guidance and coaching/mentoring to team members and other project leaders as appropriate
Building key relationships with customers and stakeholders relating to their project(s)
Serving as a subject matter expert for the Quality System
Practicing leadership, integrity, and vision
Identifying and implementing Quality System Process improvements
Leading the business in implementing total product lifecycle approaches
Coordinating corrective action efforts with other groups
Support efficiency improvements for business processes
Supporting product stewardship projects and activities
Unfailing commitment to the safety of Spectranetics' customers and patients
Supervisory Duties: No direct reports.
Material and Equipment Directly Used:
Spectranetics' Policies and Procedures
FDA regulations and international standards
BS Engineering discipline or higher
Seven years in the medical device industry required, with a minimum of 3 years in a management or program management capacity
Solid working knowledge of FDA Quality System Regulations and ISO 13485
Experience in new product development and/or post-market sustaining activities
Excellent written and verbal communication abilities
Excellent organization skills; thorough and detail oriented
CQE and CQM Certifications – ASQ is desirable but not required
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.