Job Description
Quality Assurance Supervisor- Simply Biotech ****
OVERVIEW **** ****
Are you looking for a new career opportunity with an exciting biotech company?! Then we've got the right team for you! In this role, you're responsible for the duties listed below.
Immediate opening for a Quality Assurance Supervisor with a biopharmaceutical company in Malvern, PA who possesses:
Email resumes to rmontillo@simplybiotech.com or call 949.204.3862
FULL DESCRIPTION : We are seeking a highly organized and detail-oriented Quality Assurance Supervisor to join our dynamic team in the medical device industry. As the Quality Assurance Supervisor, you will play a pivotal role in ensuring the highest standards of product quality and regulatory compliance. Your expertise will be instrumental in maintaining our reputation for delivering safe and effective medical devices to our customers and patients. In this role, you will oversee various quality assurance activities, with a significant focus on management of the Quality Control department and final release of product.
The selected candidate will be responsible for:
**Quality Management / Leadership:
**· Lead the development, implementation, and continuous improvement of the Quality Management System (QMS) in accordance with relevant industry regulations, standards, and guidelines
· Lead, mentor, and manage a dedicated quality control team, providing guidance, training, and performance feedback
· Coordinate team activities and assignments to ensure efficient and effective execution of quality assurance responsibilities, including coordination between two different company facilities
**Inspections and Documentation:
**· Oversee and execute comprehensive inspections of all relevant paperwork and documentation associated with the manufacturing, testing, and distribution of medical devices
· Ensure that all records, including batch records, specifications, procedures, and protocols, are complete, accurate, and compliant with regulatory requirements
· Identify and rectify any discrepancies, errors, or gaps in documentation, working closely with relevant departments to resolve issues promptly
**Quality Audits and Inspections:
**· Plan, coordinate, and participate in internal and external quality audits and inspections, ensuring readiness and successful outcomes
· Collaborate with auditors and regulatory agencies, addressing findings and implementing corrective and preventive actions (CAPAs) as necessary
**PNR (Product Nonconformance Review):
**· Manage the assessment and disposition of nonconforming products, ensuring that appropriate actions are taken in alignment with established procedures and regulatory requirements
· Collaborate with manufacturing, engineering, and supply chain teams to determine the disposition of nonconforming materials and products
**Complaint Management:
**· Oversee the complaint handling process, ensuring timely and thorough investigation, resolution, and documentation of customer complaints
· Analyze complaint data to identify trends, implement corrective actions, and enhance product quality and customer satisfaction
**Data Analysis and Reporting:
**· Analyze quality data, generate reports, and present findings to senior management to drive informed decision-making
The selected candidate will also possess:
· Bachelor's degree in a relevant scientific or engineering discipline
· A minimum of 7+ years of experience in quality management within the medical device industry
· In-depth knowledge of relevant regulations, such as FDA 21 CFR Part 820, EU MDR, MDSAP and ISO 13485
· Strong attention to detail and excellent analytical skills
· Exceptional communication and interpersonal abilities
· Proven experience in conducting paperwork inspections and document reviews
· Previous experience with quality audits and regulatory inspections
· Proficiency in using quality management tools and software
Salary Range: $80k-$90k/yr
For immediate and confidential consideration, please email your resume to rmontillo@simplybiotech.com or call 949.204.3862 . More information can be found at www.simplybiotech.com