Senior Quality Engineer

Description

Position Summary:

The Senior Quality Engineer will be primarily responsible for supporting the delivery of the Quality Assurance / Regulatory functions on an on-going basis in alignment with Quality Management System to ensure compliance, to meet business needs and customer expectations. Responsible for the execution of the various processes and systems related to the Quality Compliance function, but not limited to inspection readiness, inspection management, product complaint management, risk management, and quality incident escalations. The role will entail identifying and implementing continuous improvement initiatives related to the site’s Quality Management System.

This is a key position associated with ASP Global’s strategic direction and will report to the Vice President of Quality and Regulatory Compliance.

Essential Duties and Responsibilities:

To perform this job successfully, an individual must be able to perform essential duties to satisfaction. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individual’s disabilities to perform the essential functions.

· Ensure implementation and rigor of product development processes and design control procedures are in compliance with the QMS.

· Provide support for post-market surveillance activities including but not limited to complaint investigations, Operations change control/ risk assessments, document control, Quality Systems improvements, Regulatory & certification audit readiness, and internal audits,

· Problem-solving of technical issues related to design, development, and manufacturing supporting compliant, nonconformance, CAPA and SCAR investigations.

· Responsible for coordinating and managing project activities across all cross-functional team members to ensure timely completion of milestones.

· Serve as Audit Quality Administrator and subject matter expert during internal and external audits/inspections.

· Generate, review, approve, and/or execute changes and/or validations for Quality Systems to ensure compliance to US and International requirements for Quality Systems activities.

· Ensuring that the external manufacturers are qualified and monitored in compliance with the Supplier Quality Management program which may include validation/verification review, leading supplier quality audits, developing quality agreements, participating in monitoring activities, issuing SCARS, etc.

· Support complaint investigation activities within cross-functional teams and lead appropriate analysis of the information that supports continuous improvement in a timely manner. Ensure corrective and preventative actions are effective.

· Lead and ensure compliance on Risk Management files which include Design FMEA & Process FMEA.

· Experience in interpreting US and international regulatory requirements and successful submissions for medical devices (510k’s, CE mark technical files, etc.).

· In-depth knowledge of applicable global regulatory compliance requirements for personal protective equipment (PPE), drugs, cosmetics, and medical devices, including US FDA, NIOSH, Health Canada, TGA, and EUMDR.

· Knowledge and experience with ISO 13485 and ISO 9001 requirements is required.

Qualifications

Competencies:

To perform this job successfully, an individual should demonstrate the following competencies:

· Attention to Detail - Thoroughness in accomplishing a task through concern for all the areas involved, no matter how small. Monitors and checks work or information and plans and organizes time and resources efficiently.

· Problem Solving - Builds a logical approach to address problems or opportunities or manage the situation at hand by drawing on one’s knowledge and experience base and calling on other references and resources as necessary.

· Discernment/Judgement - Makes decisions authoritatively and wisely, after adequately contemplating various available courses of action.

· Communication (Oral and Written) - Effectively transfers thoughts and expresses ideas orally or verbally in individual or group situations.

· Drive for Results - Demonstrates concern for achieving or surpassing results against an internal or external standard of excellence. Shows a passion for improving the delivery of services with a commitment to continuous improvement.

· Initiative - Does more than is required or expected in the job; does things that no one has requested that will improve or enhance products and services, avoid problems, or develop entrepreneurial opportunities. Plans ahead for upcoming problems or opportunities and takes appropriate action.

Education and/or Experience:

· Bachelor's Degree in a science, engineering, or related discipline (Preferred: Chemical, Polymer, Biomedical, Materials Science, Industrial, Mechanical)

· 5 years of progressively increasing responsibility in a medical device or related industry/organization

· Certified Quality Engineer and/or Certified Reliability Engineer, preferred

· Lean Six Sigma Green Belt or Black Belt, preferred

· Terminal sterilization of medical devices knowledge (EO/Gamma/I-Beam), including validation processes, preferred

Skills and Knowledge Requirements:

· Excellent working knowledge of 21 CFR 820, EU MDR, ISO 13485, and ISO 9001

· Strong analytical, problem solving and technical writing skill

· The ability to work with a variety of disciplines and levels of staff both internally and externally

· Ability to work independently or as an integral part of a cross-functional team

· Able to understand, interpret, explain, and resolve technical issues

· Strong project management and organizational skills

· Experience with statistical analysis and associated software

Physical Demands:

Individuals may need to sit or stand as needed, may require walking primarily on a level surface for periodic periods during the day, reaching above shoulder heights, below waist or lifting as required to file documents or store materials throughout the day. The position may require lifting heavy supplies and office materials. Travel up to 10% may be required.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. For the most part ambient room temperatures, lighting and traditional office equipment as found in a typical office environment.

Salary : $75,000 - $95,000