- 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
- Organizes data collection and information analysis; creates reports
- 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
- Works according to the deadlines for maintaining QMS
- Performs other duties and responsibilities as required
- 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
- 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.
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Quality Assurance Manager - Erie, United States - Adecco
Description
Job Description
Job DescriptionAdecco is seeking a Quality Assurance Manager for a local client in Erie, PA. Apply now for instant considerationResponsibilities for this Quality Assurance Manager position include:
Preferred Qualifications:
ISO:
13485, 21 CFR Part 820.
Pay Details: $60.00 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan.
In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/DisabledTo read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to
The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.
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