Stryker is hiring a Staff Chemist, Quality Control to support our Joint Replacement division in Mahwah, NJ who will be lead the performing analytical chemistry testing to determine product safety of the entire product portfolio.
What you will do:
Lead analytical chemistry testing for new product development, existing medical device changes, and lab validation activities.
Oversee daily lab operations, including preventative maintenance, calibration, purchasing, metrics, and sample organization.
Execute and validate analyses using GC-FID, GC-MS, ICP-MS, TOC, and other laboratory equipment.
Manage departmental initiatives, setting timelines, milestones, and aligning policies with industry best practices and regulatory requirements.
Evaluate test data, approve internal testing documentation, and conduct root cause analyses and equipment troubleshooting.
Partner with cross-functional teams (RA, AO, Ops) to ensure alignment with business unit project timelines.
Present lab KPIs and findings to management and cross-functional stakeholders.
Coach, mentor, and train junior scientists and team members in analytical chemistry and lab best practices.
What are we looking for:
Required
Bachelor of Science in Chemistry, Biochemistry, Chemical Engineering or a similar science degree with 4+ years’ experience in analytical chemistry testing is required.
Minimum 3 years’ experience in medical device, pharmaceutical, cosmetic or chemical industry.
Experience leading or writing analytical test method validations for TOC, UV/VIS, HPLC, GC, or ICP instrumentation using ISO, ICH, or USP standards.
Knowledge of ANSI, AAMI, ISO, ICH, or USP guidelines for residual chemical analysis.
Minimum 3 years’ experience in using HPLC-MS, HPLC-UV, GC-MS, GC-FID, or ICP-MS.
Preferred
Master of Science in Chemistry, Biochemistry, Chemical Engineering or a similar science degree.
Demonstrated ability to manage day-to-day activities within a chemistry lab such as familiarity with calibration schedules, purchasing, sample organization, and lab metrics.
2+ years’ experience conducting root cause analysis or out-of-specification investigations.
Knowledge of cGLP and cGMP processes with experience in following standards such as ISO 17025, USP 1225 or USP 232.
Experience in LIMS (i.e. Labvantage, ilab) and statistical software (i.e. Minitab).
Travel Percentage: 10%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.