- This position will support core quality system processes to ensure compliance with applicable medical device regulations (FDA, EU, Health Canada, ISO 13485) by providing operations support, tracking quality metrics, facilitating training programs, reviewing quality system records, and analyzing data.
location: Warrendale, Pennsylvania
job type: Contract
salary: $75.00 - 82.76 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Supports the CAPA, Internal Audit, document control, complaint investigation, and other quality system processes to ensure conformance to applicable regulations, standards, and corporate policies.
- Updates and maintains QMS SOPs, work instructions, and forms based on interpretation of applicable quality standards, internal gap assessments, and audit findings to ensure ongoing regulatory compliance and audit readiness.
- Utilizes basic project management skills for timely completion of projects in support of plant goals.
- Assist in updating supplier quality files & performance scorecards with accurate, current documentation of supplier performance in alignment with requirements.
- Supports in-depth audits of Quality System elements against internal and external requirements including regulatory requirements, industry standards, regulatory guidance documents, corporate policies and standard operating procedures, and local procedures, documents, and records
- Provide support for regulatory compliance processes such as Product Field Action assessments and execution.
- Collaborates with other departments and cross-functional teams on daily tasks and projects, such as CAPA records complaint investigations, and internal audit reports/ responses.
- Initiate and manage CAPA records and facilitate board meetings to ensure on-time completion & escalation as needed.
- Work cross-functionally to support investigations teams and root cause analyses and provide well-documented corrective and preventive action plans for identified issues
- Compiles, reviews, analyzes, and distributes monthly metric reports for CAPA, Internal Audit, Complaint Investigation, and other quality system processes to identify trends and potential process improvements.
- Ensures effective communication of audit activities, status and metrics to leadership throughout the organization
- Supports preparation for and hosting of external audits by regulatory agencies and notified bodies
qualifications:
- Bachelor's Degree in science or engineering field
- Proficiency with Microsoft Word, Excel, and Power Point.
- 1-3 years' experience in a medical device, pharmaceutical industry preferred.
- ASQ Certified Quality Auditor, Certified Biomedical Auditor and/or ISO 13485 Lead Auditor certification preferred.
- Knowledge of quality systems requirements (e.g. 21 CFR Part 820, ISO 13485, MDD, etc.) preferred.
- Good verbal and written communication skills.
- Basic analytical, trouble-shooting, and problem solving skills
skills: MS-EXCEL, Corrective and Preventive Actions (CAPA), Quality Assurance (QA)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Any consideration of a background check would be an individualized assessment based on the applicant or employee's specific record and the duties and requirements of the specific job.
