Staff Chemist, Quality Control

Stryker is hiring a Staff Chemist, Quality Control to support our Joint Replacement division in Mahwah, NJ who will be performing chemistry testing to determine product safety of the entire product portfolio.

Who we want: 

• Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations. 

• Self-directed initiators. People who take ownership of their work, results-oriented, and need no prompting to drive productivity, change, and outcomes. 

• Team-player. People who can collaborate globally and thrive when developing lasting interpersonal relationships.  

What you will do:  

• 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 including (RA, AO, Ops) to ensure business unit project timelines are met. 

• Present lab KPIs to management and cross-functional partners. 

• Define policies and procedures to align to 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 area of analytical chemistry.  

What are we looking for:  

Required

• BS in Chemistry/Biochemistry, Chemical Engineering or a similar Science degree with 4+ years of medical device, pharmaceutical or chemical industry required

• 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

• 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 can 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 in critical and analytical thinking. 

• Highly developed problem-solving skills.  

• Scientific and technical writing and leadership skill. 

• Demonstrated ability to work independently.