Develops and implements company and regulatory quality standards in the manufacturing facility. Knowledgeable of industry and governmental regulations affecting product quality. Develops, implements, revises and maintains quality standards, tools and methods for processing materials into finished products.
Provide quality support for new product development activities of medical device products following design control requirements and internal procedures. Provides general engineering services and support for product manufacturing, quality control and new product development. The quality engineer is provided limited direction from the Manager to maintain the complaint and investigation processes and can perform all activities and takes a lead role with projects and product support.
Essential Duties and Responsibilities:
- Compiles and analyzes quality system metrics (e.g. management review, compliance metrics, post market quality assurance, etc.) in order to ensure key process indicators are identified, measured and action driven. Identifies unacceptable trends and drives suitable corrective action
- Facilitate and actively contribute to the risk management activities per ISO 14971:2019: Risk Management Plans, FMEA’s, Risk Control, etc. for new and released products
- Supports Materials nonconformance investigation, disposition and release activity as applicable
- Creating appropriate harm/hazard analysis/health hazard assessment for issues potentially impacting patient outcomes
- Remediation of product documentation for changes in product compliance for new or updated regulations (i.e., MDR, IVDR)
- Identify, investigate and implement corrective and preventive actions
- Lead projects related to NPI and Transfers
- Prepare technical product documentation including design history files, drawings, bills of materials, test protocols and reports, engineering change orders (ECO), etc.
- Work with manufacturing engineer/process engineer to ensure necessary process controls are in place
- Write, review and/or approve reports for: test method validations, design verification, design validation, and process validations (IQ, OQ, PQ)
- Participate in supplier quality management assessment and qualification as required
- Lead or participate in product, component or assembly qualifications at suppliers
- Write, review and / or approved quality plans to support product activities both internal and external
- Participate in project teams and company initiatives to assure compliance with Quality System requirements while achieving company objectives
- Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE)
- Bachelor’s degree in related discipline. Relevant work experience may offset the educational requirement
- Certified Quality Engineer (CQE) and/or Certified Quality Auditor (CQA) certificates from American Society for Quality (ASQ) are a plus
- 7+ years of experience as a Quality Professional in the Medical Device industry required
- Knowledge of ISO 13485 is essential as well as FDA and cGMP regulations and documentation practices
- Onward Search is an equal opportunity employer, dedicated to a policy of non-discrimination in an employment with regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, veteran status or any other classification protected by federal, state and local laws and ordinances. Candidates must be at least 18 years old to be considered for employment. EOE/M/F/D/V/SO.
- In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.
- The client is unable to support 1099 / Corp-to-Corp or Independent Contractor arrangements at this time. All freelancers will be paid as W2 employees.
- Onward Search is a drug-free workplace.
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