Staff Chemist, Quality Control Specialist

2 weeks ago

Mahwah, New Jersey, United States Stryker Full time
Job Summary

We are seeking a highly skilled and detail-oriented Staff Chemist, Quality Control to join our team at Stryker. As a key member of our Joint Replacement division in Mahwah, NJ, you will be responsible for performing chemistry testing to ensure the safety of our medical devices.

Key Responsibilities
  • Lead analytical chemistry testing for new product development and changes to medical devices
  • Manage day-to-day lab activities, including coordination of preventative maintenance, calibration, purchasing, lab metrics, and sample organization
  • Execute analysis using GC-FID, GC-MS, ICP-MS, and TOC, as well as other laboratory equipment
  • Develop and implement departmental initiatives, including setting timelines and milestones
  • Evaluate test data to approve all internal testing documentation
  • Collaborate 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 leaders and regulatory requirements
  • Lead root cause analysis, equipment troubleshooting, and out-of-specification investigations
  • Lead validation activities within the lab
  • Coach, mentor, and train junior scientists and other functions in 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 for residual chemical analysis for medical devices
  • Preferred experience in LIMS and statistical software
  • 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 to work effectively in a fast-paced, multi-disciplinary team environment
  • Strong critical and analytical thinking, problem-solving skills, and scientific and technical writing and leadership skills
  • Demonstrated ability to work independently
Benefits

Stryker offers a comprehensive benefits package, including medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program, and tobacco cessation program. Additionally, we offer a 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.

Stryker is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive and respectful work environment that values diversity and promotes equal opportunities for all employees.

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