Staff Chemist, Quality Assurance

5 days ago

Mahwah, New Jersey, United States Stryker Full time
{"title": "Staff Chemist, Quality Control", "description": "Job Summary

Stryker is seeking a Staff Chemist, Quality Control to support our Joint Replacement division in Mahwah, NJ. The successful candidate will be responsible for performing chemistry testing to determine product safety of our entire product portfolio.

Key Responsibilities
  • Lead analytical chemistry testing for new product development and changes to medical devices currently on the market.
  • Lead day-to-day lab activities, including coordination of preventative maintenance, calibration, purchasing, lab metrics, and sample organization activities.
  • Execute analysis using GC-FID, GC-MS, ICP-MS, and TOC as well as other laboratory equipment.
  • Lead departmental initiatives, including setting timelines and milestones.
  • Evaluate test data to approve all internal testing documentation.
  • Partner with cross-functional teams to ensure business unit project timelines are met.
  • Present lab KPIs to management and cross-functional partners.
  • Define policies and procedures to align with best practices, benchmarking against industry leads and regulatory requirements.
  • Lead root cause analysis, equipment trouble shooting, and out-of-specification investigations.
  • Lead validation activities within the lab.
  • Coach, mentor, and train junior scientists and other functions in the area of analytical chemistry.
Requirements
  • BS in Chemistry/Biochemistry, Chemical Engineering, or a similar Science degree with 4+ years of medical device, pharmaceutical, or chemical industry experience.
  • Demonstrated ability to manage day-to-day activities within a chemistry lab.
  • Knowledge of cGLP, cGMP, ANSI, AAMI, ISO, FDA, and USP guidelines to residual chemical analysis for medical devices.
Preferred Qualifications
  • Preferred experience in LIMS (i.e. Labvantage, ilab) and statistical software (i.e. Minitab).
  • Must possess effective communication, project management, and influencing skills, as well as the ability to manage multiple tasks simultaneously.
  • Excellent written and oral communication skills, including strong formal presentation and analytical skills.
  • Ability and desire to work effectively in a fast-paced, multi-disciplinary team environment.
  • Strong critical and analytical thinking skills.
  • Highly developed problem-solving skills.
  • Scientific and technical writing and leadership skills.
  • Demonstrated ability to work independently.
About Stryker

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.

", "lang_code": "en"}

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