Emerge is currently recruiting qualified candidates for a direct hire Quality Assurance Manager job in Erie, PA for our client, a growing medical field manufacturer. The Quality Manager will provide support and makes recommendations to the CEO and senior staff for strategic planning purposes. We are seeking candidates with experience managing or supervising quality in a medical, medical device, pharma, or similar industry. This position can be a hybrid role, working remotely but will require time at the facility and on the production floor. Candidates that have experience in Regulatory Affairs qualify for additional salary and job duties. Salary is based on experience in the ISO13845 field.
Responsibilities for the Quality Manager job in Erie, PA include:
- Primary interface with FDA, MDSAP and ISO auditor(s)
- Interface with engineering in the risk management process
- Works with state, national and international stakeholders to improve quality and safety of products
- Develops inspection plans/criteria, along with Engineering staff, per prevailing standards
- Performs inspection as needed
- Develops and implements methods to inspect and evaluate the reliability of manufacturing process, products, and production equipment(s). Defines and maintains process control and equipment calibration
Makes sure processes (including outsourcing) and production adhere to quality standards
Responsible for overseeing/maintenance of the internal audit program
- Performs external audits for new/current suppliers
- Does analysis of field failures and customer complaints
- Maintains Quality Management System
- Recommends effective corrective and preventative actions
- Oversees material traceability and lot control
- Develops an integrated, system-wide plan for Quality and performance improvement
- Provides evidence-based recommendations for improving business and manufacturing processes
- Bachelor’s Degree in Engineering, Business, or the Sciences or (5) years’ progressive experience in a production environment (medical device/equipment preferred).
- Prior experience in ISO certified companies; familiarity with ISO: 13485, 21 CFR Part 820.
- Knowledge of relevant regulatory requirements preferred.
- MDSAP knowledge a plus
- 93/42/Medical Device Regulations and MDR knowledge a plus
- Experience with FDA Submittals preferred
- Experience with Notified Body Requirements
- Knowledge of Risk Management
- Ability to read blueprints and knowledge of calibration and testing methods
- Strong computer skills, proficient in Microsoft Office.
- Knowledge of concepts and methodologies of data analysis and statistical analysis.
- Certifications including MDD, MDR, ISO 13485 internal auditor a plus.
If you would like to apply for this position, please click Apply Now. Thank you in advance for applying, however, only qualified candidates will be contacted.
Who is Emerge? We are a global talent solutions company working with clients all over the world. We deliver managed sales, services, marketing, and business solutions to our clients. We are committed to your success, working quickly and efficiently to provide tangible, measurable results. #INDDH