Quality Associate ll

Quality Associate ll

Requirements

• BS in business/science or equivalent.
• Preferred 3-5 years proven experience in Quality with a medical device/Pharma company or other similarly regulated industry.
• Strong interpersonal skills and great attention to detail are vital.
• Must be a strong teammate with good problem solving, and good verbal and written communication skills.
• Must have the ability to manage people, encourage collaboration and drive decisions.
• Able to balance multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
• Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.
• Must have basic English written and oral communication skills adequate to connect with other team members.

Responsibilities

• Leads ongoing, daily departmental operations related to Annual Product Quality Review (APQR) and Management Review.
• 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 vital actions.
• Determine the logic, adequacy and efficiency of processes, systems and related requirements.
• Develop plans to accurate identified risks including areas of non-conformance. Advise 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 mentor 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.
• Coordinates 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.
• Sustain a clean and safe work area using 6S principles
• Learn, understand and apply thorough quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)

Preferred Qualifications

• 3-5 years proven experience in Quality with a medical device/Pharma company or other similarly regulated industry.