Quality Associate II

Immediate need for a talented Quality Associate II. This is a 12+ months contract opportunity with long-term potential and is located in Round Lake, IL (Onsite). Please review the job description below and contact me ASAP if you are interested.

Job ID: 25-90715

Pay Range: $33 - $35/hour.  Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• Responsible for providing Quality support and oversight via direct staff supervision or process/area responsibilities.
• Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and quality practices.
• This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work.
• The incumbent will perform other duties assigned. Leads ongoing, daily departmental operations.
• May include the supervision of assigned personnel in achieving defined quality goals in an efficient, accurate and timely manner; Interview/hire, evaluate, train and develop direct reports Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude.
• Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques.
• Work closely with production supervisors, quality, engineering and other internal groups to accomplish the above and influence necessary actions.
• Determine the logic, adequacy and effectiveness of processes, systems and related requirements.
• Develop plans to correct identified risks including areas of non-conformance. Inform management and implement approved corrective action plans.
• Serve as Subject Matter Expert (SME) by maintaining a high level of expertise in current regulatory requirements.
• Provide training and coaching to local employees and others as needed on relevant area(s).
• When required, assist other Quality areas in the successful performance of these activities.
• Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
• Participate in external assessments and audits by evaluating and solving product/process problems by providing technical, analytical and supervisory skills Support process with timely closure of observations/audit items.
• Oversees audits of various reports (Protocols, Qualifications, Regulatory Submissions, etc.) Participate in QA/QC multi-site projects in the role of contributor, coordinator or lead. Other duties, tasks or projects as assigned.
• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Key Requirements and Technology Experience: 

• Key Skills; BS in business/science or equivalent.
• 3-5 years of exp in Quality with a Medical.
• Knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
• List knowledge, skills, and/or abilities required.
• Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
• Strong interpersonal skills and great attention to detail are necessary.
• Must be a strong team player with good problem solving, and good verbal and written communication skills.
• Must have the ability to manage people, encourage teamwork and drive decisions.
• Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
• Include the education and experience that is necessary to perform the job satisfactorily.
• BS in business/science or equivalent. 3-5 years exp in Quality with a medical.

Our client is a leading medical technology Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

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