Posted in General Business 15 days ago.
Location: Horseheads, New York
At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, manufacturing, and supply chain solutions. With over 50 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise to deliver both scalable and customized solutions. Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe.
Jabil is seeking a Senior Quality Systems Engineer to work for the Elmira, NY location. The Senior Quality Systems Engineer will have the responsibility and authority to lead assigned Quality System processes. The qualified candidate will also lead internal audits, customer audits, ISO Registration audits, and FDA Inspections and when required prepare submissions and responses to FDA and ISO Registrars.
Potential travel up to 10% throughout the year.
Competitive Salary and Benefits Offered!
ESSENTIAL DUTIES AND RESPONSIBILITIES
Leading internal audits and supplier audits.
Leading the readiness program for ISO Registration audits, FDA Inspections, and customer audits.
Preparing submissions and responses to FDA and ISO Registrars.
Acting as the primary compliance contact for site departments, business units, and corporate functions.
Acting as a subject matter expert for the Quality Systems and Compliance programs.
Ensuring the site’s quality system development, effective maintenance, and continued compliance with business unit requirements, medical device regulations, and standards (i.e., U.S. – FDA, ISO 13485, Anvisa).
Supporting the effectiveness of the Quality Systems and Compliance programs by working collaboratively with other stakeholders to ensure effective and compliant processes.
Performing all duties in alignment with the Jabil Corporate Code of Ethics, Corporate and Global policies, Employment Labor Laws, Health Regulatory Agency Regulations, and Safety Requirements.
May perform other duties and responsibilities as assigned.
Bachelor’s degree required in Regulatory Affairs, Engineering, Business, or similar related degree OR Master’s degree is preferred.
At least 8 years of industry experience within Quality and/or Regulatory OR a combination of education, experience, and/or training.
Experience leading and managing high-performing teams.
Knowledge of the U.S. and international medical device quality system regulations, standards, and best practices (21 CFR 820, ISO 13485)
Experience with compliance assessments, gap assessments, and risk assessments.
Experience with program change management practices, Lean or Six Sigma programs, and system integration efforts.
BENEFITS WITH JABIL
Along with growth, stability, and the opportunity to be challenged, Jabil offers a competitive benefits package that includes:
Medical, Dental, Prescription Drug, and Vision Insurance with HRA and HSA options
Employee Stock Purchase Plan
Paid Time Off
Life, AD&D, and Disability Insurance
Employee Assistance Program
Annual Merit Increases
Community Volunteer Opportunities
The pay range for this role is $96,113 - $173,004. Job-related, non-discriminatory factors used to determine the actual offered rate include qualifications and experience, geographic location, education, external market data, and consideration of internal equity. .As part of the total rewards package, this position is eligible for a short-term incentive based on performance. In addition, Jabil offers benefits to enhance your health, wealth and resilient self. These include medical, dental, and vision insurance plans; 401(k) retirement plan and employee stock purchase plan; and paid time off.
Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, age, disability, genetic information, veteran status, or any other characteristic protected by law.