Find & Apply For Technical Sales Representative Jobs in Blue Island, Illinois

Hybrid work schedule with remote work on Fridays Strongly competitive compensation with 20% bonus About Our Client Our client is a global manufacturer of products for the medical device and pharmaceutical industries. They have over 3,500 employees across the globe, with a large presence domestically and HQ in Asia. They have been in business for over 100 years, have seen steady growth, and their facility here in the Chicagoland area is

ISO 9001, ISO

14001, and

ISO 13485

certified. Job Description Quality Operations Leadership Direct day-to-day Quality Operations activities supporting manufacturing and laboratory operations. Ensure timely review and disposition of: Batch records CAPAs / Deviations / Investigations Change controls Validations Product impact assessments Lead batch disposition and product release decisions in accordance with established quality standards and regulatory requirements. Drive quality oversight on the manufacturing floor through active engagement and visible leadership. Establish robust metrics and dashboards to monitor product quality, process performance, compliance, and operational effectiveness. FDA Compliance & Inspection Readiness Ensure compliance with: 21 CFR Parts 820, 210 and 211 FDA Guidance Documents USP and compendial requirements ISO 13485 and ISO 14971, where applicable Maintain a state of continuous inspection readiness across manufacturing, laboratories, warehouses, and quality systems. Lead site preparation and hosting activities for: FDA inspections Customer audits Regulatory inspections or ISO certification Corporate audits Serve as primary Quality representative during regulatory inspections. Also provide updates or correspondence as needed to regulatory bodies. Quality Control Chemistry & Microbiology Oversight Provide strategic oversight of QC Chemistry and Microbiology operations. Ensure laboratory systems comply with FDA expectations for: Method validation Data integrity Sample management Ensure scientifically sound testing programs for: Raw materials / components / finished goods Stability programs Environmental monitoring & utilities Oversee investigation and resolution of:

OOS & OOT

results Ensure compliance with applicable USP chapters and compendial requirements. Quality System Management (QMS) Provide oversight and continuous improvement for all elements applicable to 21 CFR parts 820, 210, 211: CAPA program including investigations and non-conformances Design & Change Control Complaint Handling including all applicable post-market surveillance activities Product Quality Reviews / Annual Product Reviews Supplier Quality Management Internal Audit Training Data Integrity Documentation Management Risk Management Ensure quality systems are compliant, effective, measurable, and inspection ready. Manufacturing & Technical Operations Support Provide Quality oversight for manufacturing operations.

Support:

Process and Equipment Validations Critical utilities validation Review and approve validation protocols, reports, and quality impacting technical documents. Partner with Manufacturing to improve process capability, reduce deviations, and improve overall performance. CAPA, Deviations & Risk Management Lead investigations into: Deviations, Non-conformance's, OOS Customer complaints Ensure timely implementation of CAPAs Apply risk management principles aligned with

ISO 14971

to identify and mitigate potential product risks. Track effectiveness of corrective actions and ensure closure within defined timelines. Supplier Quality & Material Controls Lead supplier qualification and monitoring programs. Ensure compliance with material testing requirements under 21 CFR 211.84. Oversee supplier audits and quality agreements.

Ensure robust controls for:

Raw materials / Packaging components Contract laboratories Contract manufacturers MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants. The Successful Applicant Bachelor's degree in Chemistry, Microbiology, Biology, Pharmaceutical Sciences, Engineering, or related scientific discipline required. Advanced degree preferred 10+ years of progressive Quality leadership experience in FDA-regulated pharmaceutical, OTC, biologics, medical device, or combination product environments. Direct experience with FDA inspections, 483 responses, and inspection readiness Experience in pharmaceuticals, OTC products, and/or medical devices preferred. Sponsorship not provided What's on Offer Base salary of $140k-$175k depending on experience 20% annual bonus incentive BCBS Health Insurance Vision & Dental Insurance 401(k) match of 10% Paid Time Off (Plus one week shutdown between Christmas and New Years) HSA Account Tuition Reimbursement