Associate Manager, Sterility Assurance in Mahwah, NJ at Stryker Corporation

Date Posted: 10/1/2018

Job Snapshot

Job Description

Who we want

Subject Matter Expert. People will provide not only leadership but also be the go to person for the business & team for all technical challenges as it pertains to the role

Partner. People who understand the needs of a growing business & can effectively prioritize the workload of their team around customer needs

Challengers.  People who seek out the hard projects and work to find just the right solutions.

Teammates.  Partners who listen to ideas, share thoughts and work together to move the business forward.

What you will do

As an Associate Manager, Sterility Assurance you will Lead the Sterility Assurance team to ensure compliance to ANSI/AAMI/ISO, FDA Quality System Regulation, ISO13485 related to medical device sterilization, microbiology and related product and manufacturing process controls.

  • You will manage the Sterility Assurance team to drive compliance to applicable FDA, ISO, ANSI/AAMI and Company requirements, including all safety, quality and operational documentation and practices.
  • You will provide knowledge and recommendations for processing products through gamma irradiation, ethylene oxide, hydrogen peroxide gas plasma and both moist and dry heat forms of sterilization.
  • You will merge cGLP, CGMP, ANSI, AAMI, ISO, FDA, EPA and USP guidelines with actual bioburden, cytotoxicity and bacterial endotoxin test results to create knowledge that is capable of innovatively advancing quality improvement initiatives that address sterility concerns on orthopedic devices.
  • You will review/approve product and sterilization process change control documentation and specifications.
  • You will actively participate in cross-functional projects that develop and improve manufacturing processes for existing and new products. 
  • You will manage all sterilization validations, dose audits, customer inquiries specific to sterilization and cleaning, residual evaluations, and all other processes that have the potential of negatively impacting product quality from a sterility, cleanliness or biocompatibility view point.
  • You will provide vision, guidance and effective communication to all team members to ensure the team’s understanding and achievement of Quality, Cost, Delivery, Safety and Talent objectives.
  • Your  will manage, coach, mentor, and develop the performance of team to drive and support a high performance work culture; includes writing and delivering performance appraisals, administering disciplinary action, providing positive recognition, liaising with Human Resources to ensure consistency in administration and compliance with Company policies, focusing on the development of high-potential employees and crafting succession plans, and establishing a collaborative environment that encourages and supports employee engagement.
  • You will develop and manage the departmental budget.

What you need

  • Bachelor’s degrees in science or engineering
  • 8 years’ experience in Medical Device Industry

Work From Home: No

Travel Percentage: None

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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