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Posted on :
28-03-2024
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1 Vacancy
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Job Description
Req ID : 2376067
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
- Lead the coordination for required quality events - responsible for the design history file remediation project for specific medical device.
- Responsible for writing, analyzing, and executing quality requirements while verifying, validating, and making relevant changes to current design requirements.
- Support all backlog and remediation tasks.
- Make appropriate updates to current procedures and specifications.
- Design quality standards and control systems (inspect materials, equipment, processes) and determine corrective actions/solutions.
- Analyze quality performance and determine any foreseeable risks and implement process improvement.
- Ensure that processes and specifications comply with required quality standards and regulations.
- Other duties as assigned.
Requirements
- College degree in engineering or related sciences (medical device, design, quality, etc.)
- 7-10 years of experience in the medical device industry with a strong background in design verification and design validation.
- Extensive experience writing design quality requirements.
- Advanced understanding of regulatory requirements regarding design quality.
- Knoweldge of risk management and corrective action.
- Experience with various quality management systems.
- Strong knowledge of risk analysis tools.
- Excellent attention to detail and problem-solving skills.
- Goal oriented and task driven.
- Ability and willingness to travel is preferred.
Benefits
Offering a full suite of benefits, PSC Biotech is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
401(k) and 401(k) matching
PTO, Sick Time, and Paid Holidays
Education Assistance
Pet Insurance
Discounted rate at Anytime Fitness
Financial Perks and Discounts
Annual Salary Range (dependent on experience) $109,000-$173,000
Equal Opportunity Employment Statement:
PSC is committed to 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.
#LI-TW1
Minimum requirement College Degree with Science background. Extensive experience writing design quality requirements. Verifying, validating, and changing design requirements. Good understanding of regulatory requirements around design quality. Has quality management system experience. Task-driven and has a "go-getter" personality.
Employment Type
Full Time
Department / Functional Area
Key Skills
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