Sr Mgr Quality Assurance (MedTech)

Location: Jacksonville, Florida, United States of America; onsite. Travel: 20%.

Base pay: $122,000–$212,750 per year.

Company

Johnson & Johnson MedTech develops healthcare and medical technology solutions across innovative medicine and MedTech.

What you will do

• Direct quality operations for the Jacksonville Surgical Vision site, including incoming materials, in-process and final inspections and testing.
• Lead site quality systems execution and serve as the local Quality Systems Management Representative.
• Make quality decisions on nonconforming materials and escalate quality events to risk management and quality boards.
• Develop operational quality strategies with Supply Chain Operations, Franchise Quality and cross-functional partners.
• Host third-party audits, participate in management and compliance reviews, and report Quality Management System effectiveness to executive management.
• Lead quality systems improvements, inspection readiness activities and FDA follow-up communications.

Requirements

• Bachelor’s degree in Science or Engineering; an MBA is preferred.
• 15 years of experience in the medical device or pharmaceutical sector, including at least 7 years of managerial experience and 5 years in Quality.
• Experience with FDA and Notified Body agencies, including US Class III PMA and US Class II regulations, submissions, inspections and audits.
• Thorough knowledge of 21 CFR 820 and Quality Management Systems.
• Experience designing and deploying innovative quality systems and influencing senior stakeholders in a matrix organization.
• Knowledge of Process Excellence, Statistical Process Control, Applied Statistics and Six Sigma.

Nice to have

• MBA.
• Experience with ISO 9001, Good Manufacturing Practices, quality validation and standard operating procedures.

Culture & Benefits

• Inclusive work environment focused on individual dignity, diversity and employee merit.
• Eligibility for pension and 401(k) savings plans.
• Eligibility for a long-term incentive program.
• Vacation, sick time, holidays, parental, caregiver, bereavement, volunteer and military spouse leave programs.