Quality Engineer III

Alphatec Spine•Carlsbad, CA

About The Position

Develop and improve, with an emphasis on implementation, inspection methods, gages, process control techniques, standard operating procedures, inspection plans, test protocols and test reports to ensure safety, reliability and efficacy of new and current products and processes. Essential Duties and Responsibilities Support New Product Development (NPD) Lead management of Quality Engineering Deliverables for new mechanical and tissue-based products, including Design Controls. Lead Supplier Part Qualification for new products including but not limited to PQs, GR&R, correlation studies and process development. Support qualification of legal manufacturers for distributed products. Develop Quality Inspection Records (QIR), Supplier Inspection Plans, Custom Gages and associated drawings and Standard Operating Procedures Support Engineering Change Order Review. Support Design For Manufacturing (DFM) activities Technical interface with contract manufacturing Support Design Control to ensure efficient effective and compliant new product launches Support suppliers in performing IQ, OQ, and PQ processes Provide statistical support to analyze manufacturing processes and to recommend appropriate process controls for ensuring product conformance to specification. Lead Risk Management efforts in accordance with ISO 14971 Perform Failure Mode and Effects Analysis (FMEA) for design and processes. Support validations regarding sterilization, cleaning, and shipping. Participate in MDSAP, FDA, ISO, and other regulatory audits. Support Supplier Corrective Action (SCAR) process. Lead Material Review Board (MRB) and participate in Supplier Review Board (SRB). Lead Non-Conformances resolution, product reworks, and deviations approvals for medical devices in mature phase of product lifecycle. Support Design Transfer to Manufacturing (DTM) for sustaining products Identify and implement process improvements Act as liaison between supplier and company for quality related concerns or issues. Support customer complaint investigations on products manufactured by suppliers. Other duties as assigned.

Requirements

The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Extensive knowledge of both US and International medical device quality system requirements (e.g. 21 CFR Part 820, ISO 13485, MDSAP), and other applicable standards.
Recommended knowledge of AATB Regulations and 21 CFR Part 1271.
Direct experience with implantable devices, instrumentation, and disposables, in a regulatory environment (GMPs, ISO13485).
Broad experience supporting on-market / commercialized product preferred.
Experience with electromechanical and/or mechatronic devices and regulations preferred
Extensive knowledge of mechanical inspection methods and equipment
Extensive knowledge of SPC, DOE, probability, and statistics
Extensive knowledge in how to read, analyze, and interpret blueprints and GD&T
Strong ability to solve complex problems to root cause and prevent re-occurrence (CAPA)
Strong technical writing skills writing reports and procedures
Ability to effectively interact and influence with all levels of the organization
Ability to develop and maintain strong working relationships with internal and external customers and suppliers
Knowledge of Solid Works CAD software preferred
Knowledge of manufacturing methods
Working knowledge of lean principals and implementation
Detail Oriented
Strong project management skills
Good decision-making skills and judgment
Strong initiative
Ability to execute plans/strategies to completion
Robust understanding of cleanability/sterilization (steam, EtO, and Gamma) including dose mapping and dose audits.
Extensive knowledge of biocompatibility requirements
Must be able to travel up to 5% of the time
Minimum of 5 years related experience.
Must have a minimum of 1 year in medical device environment.
Prefer experience with electromechanical and/or mechatronic devices and regulations
For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).

Nice To Haves

Recommended knowledge of AATB Regulations and 21 CFR Part 1271.
Broad experience supporting on-market / commercialized product preferred.
Experience with electromechanical and/or mechatronic devices and regulations preferred
Knowledge of Solid Works CAD software preferred
Prefer experience with electromechanical and/or mechatronic devices and regulations

Responsibilities

Support New Product Development (NPD)
Lead management of Quality Engineering Deliverables for new mechanical and tissue-based products, including Design Controls.
Lead Supplier Part Qualification for new products including but not limited to PQs, GR&R, correlation studies and process development.
Support qualification of legal manufacturers for distributed products.
Develop Quality Inspection Records (QIR), Supplier Inspection Plans, Custom Gages and associated drawings and Standard Operating Procedures
Support Engineering Change Order Review.
Support Design For Manufacturing (DFM) activities
Technical interface with contract manufacturing
Support Design Control to ensure efficient effective and compliant new product launches
Support suppliers in performing IQ, OQ, and PQ processes
Provide statistical support to analyze manufacturing processes and to recommend appropriate process controls for ensuring product conformance to specification.
Lead Risk Management efforts in accordance with ISO 14971
Perform Failure Mode and Effects Analysis (FMEA) for design and processes.
Support validations regarding sterilization, cleaning, and shipping.
Participate in MDSAP, FDA, ISO, and other regulatory audits.
Support Supplier Corrective Action (SCAR) process.
Lead Material Review Board (MRB) and participate in Supplier Review Board (SRB).
Lead Non-Conformances resolution, product reworks, and deviations approvals for medical devices in mature phase of product lifecycle.
Support Design Transfer to Manufacturing (DTM) for sustaining products
Identify and implement process improvements
Act as liaison between supplier and company for quality related concerns or issues.
Support customer complaint investigations on products manufactured by suppliers.
Other duties as assigned.