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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).

Health benefits include: 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. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

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.