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Product Release Specialist

2 months ago

Peachtree Corners, United States Intuitive Full time
Job DescriptionJob DescriptionCompany Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

Primary Function of Position:

The Product Release (PR) Specialist is responsible for reviewing device history records (DHRs) for accuracy and completeness, certifying compliance to product specification and traceability requirements, and ensuring that any deviations from the manufacturing process were properly recorded and authorized by members of the appropriate departments.

The Product Release (PR) Specialist receives guidance on workload prioritization from the team lead or supervisor but is ultimately responsible for organizing and executing their projects and daily standard workload in a manner which meets the schedules of the operational teams whom they support.

Essential Job Duties:

  • Product Release
    • Reviews DHRs for da Vinci systems, instruments, and accessories for compliance to product specifications and company traceability requirements, creating certification documents and authorizing release of product for distribution to customers and New Product Introduction (NPI) launches.
    • Reviews and approves records from sterilization sub-contractors to assure sterility of single use products.
    • Ensures that any non-conformances or deviations are properly approved and documented in the DHR.
    • Works collaboratively with internal customers to resolve DHR issues in a timely manner.
    • Reports on workload status regularly within the team and identifies issues which pose a potential risk to team goals.
  • Performs inventory transactions and ensures that released products are transacted in a timely manner to maintain inventory accuracy for department inventory locations.
  • Participates in department process improvement projects or other activities as directed by management.
Qualifications

Required Skills and Experience:

  • Team-Oriented: Approaches their work selflessly and without ego, making an honest effort to manage their own assigned workload, communicating openly and in a timely manner when deliverables are at risk, and effectively seeking opportunities to ask “How can I help?”  Freely shares information and makes it a priority to mentor their peers when the opportunity presents itself.
  • Quick Study & Continuous Learner: Demonstrates aptitude for learning new processes quickly, closely seeks deeper understanding of processes and functions critical to their role.  Strives to understand the bigger picture and how their role supports key company targets.
  • Perceptive & Detail Oriented: Skilled at sensing variations from the norm and thoroughly investigating whether compliance to company process has been maintained.  Demonstrates ability to execute competently and consistently to fundamental job skills while advancing knowledge in more complex disciplines.
  • Initiative & Follow-through: Seeks opportunities to improve departmental process and expand personal contributions.  Can be relied upon to complete commitments without excessive follow-up.
  • Good Judgment: Exceptional ability to draw correlations to prior experience and identify precedent in ambiguous circumstances.  Demonstrated track record of making good decisions.
  • Ethical & Independent: Demonstrates recognition of the criticality of the job function and strives to conduct themselves in a manner which does not invite doubt about their ability to consistently execute process without direct supervision.  Does not cut corners or bow to external pressure to compromise on requirements.
  • Effective Communicator: Excellent verbal and written communication skills.  Skilled at making use of visual aides to convey complex concepts to diverse audiences.
  • Exceptional analytical, problem-solving, and root-cause analysis skills
  • Excellent verbal and written communication
  • General familiarity with spreadsheet, word processing, and email software
  • Understanding of, or aptitude to understand, Medical Device QMS and regulatory requirements including, but not limited to, ISO13485 and U.S. FDA 21CFR820

Required Education and Training:

  • Minimum have a GED or high school diploma.
  • Minimum 2+ years of operational experience in a Product Quality or certified (e.g., FDA, ISO, Mil-Spec, etc.) manufacturing environment

Working Conditions:

  • Role is full-time onsite.
  • Must be available to manufacturing teams, and for specialized roles.
  • Must be able walk long distances to validate release forms.
  • OT will be required as needed per business need or per Supervisor/Manager discretion.
  • Must be available to travel as needed 5-10%.

Preferred Skills and Experience:

  • Bachelor's or Associate Degree Preferred


Additional Information

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.