City of Industry, California, United States · Hybrid
$120k–$155k/yr
Senior
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requi…
Skills: Packaging Design, Labeling Compliance, Medical Device Regulations, FDA Regulations, ISO Standards
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$120k–$155k/yr
Contract, Temporary
bachelor degree
Medical, Sick Time
Posted 5d ago
~40 hrs/week
Responsibilities
Design, develop, and implement packaging and labeling solutions for medical device products ensuring regulatory compliance. Collaborate with cross-functional teams to manage design controls, validation activities, and technical troubleshooting.
Requirements
Requires a Bachelor's degree in Engineering and at least 5 years of experience in packaging or labeling within the medical device industry. Must have strong knowledge of FDA regulations, ISO standards, and quality system requirements.
Full job description
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.
Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.
The Experience
With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.
At PSC Biotech®, it’s about more than just a job—it’s about your career and your future.
Your Role
We are hiring an experienced Packaging & Labeling Engineer to support the design, development, and implementation of packaging and labeling solutions for medical device products. This is opportunity focuses on ensuring packaging and labeling systems meet regulatory requirements, quality standards, and business objectives while prioritizing timely execution and project delivery.
The ideal candidate will have experience within the medical device industry, a strong understanding of packaging and labeling design controls, and familiarity with applicable ISO standards and regulatory requirements.
This is a 3-4 month contracted hybrid role. No sponsorship is available at this time.
Develop, review, and support packaging and labeling designs for medical device products.
Ensure packaging and labeling activities comply with applicable FDA regulations, ISO standards, and internal quality system requirements.
Collaborate with cross-functional teams including Quality, Regulatory Affairs, Manufacturing, Supply Chain, and Product Development.
Support design control activities, documentation, and change management processes related to packaging and labeling.
Review packaging specifications, labeling content, artwork, and associated documentation for accuracy and compliance.
Participate in risk assessments and identify opportunities to improve packaging performance, product protection, and labeling effectiveness.
Assist with packaging validation activities, including test protocol development, execution, and reporting.
Support implementation of packaging and labeling changes while maintaining compliance with quality and regulatory requirements.
Troubleshoot packaging and labeling issues and provide timely technical solutions.
Drive project deliverables and meet aggressive timelines while maintaining quality and compliance standards.
Requirements
Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, or a related technical discipline.
5+ years of experience in packaging and/or labeling engineering within the medical device industry.
Strong knowledge of FDA medical device regulations, design controls, and quality system requirements.
Familiarity with applicable ISO standards and related medical device regulations.
Experience developing and implementing packaging and labeling solutions for commercial medical device products.
Working knowledge of risk management, change control, verification, and validation processes.
Experience reviewing packaging specifications, labeling content, artwork, and associated documentation for regulatory compliance.
Ability to work independently and drive deliverables with minimal oversight in a fast-paced environment.
Strong communication and collaboration skills with cross-functional teams including Regulatory Affairs, Quality, Manufacturing, and Product Development.
Packaging validation and labeling compliance experience.
Experience supporting product launches, remediation activities, or packaging/labeling design changes.
Benefits
W2 Temp roles include our Medical and Sick Time benefits
Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $120,000 - $155,000 annually. The salary offered may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.
Equal Opportunity Employment Statement
PSC Biotech is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.
PSC Software®, a division of PSC Biotech® Corporation, provides inspection management and enterprise quality management software solutions that enable businesses to safely and efficiently deliver their products to market. Applications developed by PSC Software® address the needs of organizations that must maintain compliance in regulated industries. Our principle is that software should be affordable and user-friendly in order to provide a competitive advantage to our customers.
To learn more, visit www.pscsoftware.com.
Offices: 700 Corporate Center Dr, Pomona, CA 91768, US
EQMSenterprise quality management softwareauditinginspectionsregulatory compliancedocument management21 CFR Part 11workflow managementcloud-basedhosted
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