Description

SUMMARY: 
The Quality Engineer I is responsible for supporting process improvements, risk management activities, complaint process, design control activities, customer/ISO/FDA audits, clean room activities and non-conforming material as it relates to the sustainment of current products and/or New Product Development (NPD) projects.

The Quality Engineer I participates in review and approval of Quality System documents, resolves quality issues and ensure quality control of products and processes, in compliance with all applicable company policies and procedures.

DUTIES AND RESPONSIBILITIES:
• Assumes the lead role for clean room activities including monitoring and maintaining actions.
• Follows all Quality System requirements and company procedures ensuring regulatory requirements are met in an ethical manner.
• Meets commitments on time with accuracy and attention to detail.
• Maintains current knowledge base of existing and emerging regulations, standards, or guidance documents.
• Develop validation and/or verification protocols for changes related to process improvements; execute validations/verifications and report on the conclusions to support process improvements. 
• Quality Representative for process and software validations (may require writing, reviewing, executing, analyzing and/or reporting on test protocols).
• Maintains a working knowledge of applicable statistical techniques for validation and process capability/performance purposes.
• Quality Representative for Risk Management Activities for existing products.
• Provide interpretive assistance, to all departments, regarding quality documents.
• Support training on Manufacturing and Quality System documents. 
• Conduct customer complaint investigations, determine root cause and implement corrective and preventive actions. Complete investigation write-ups.
• Quality Representative for Design Control Activities.
• Release documents via the change control process as necessary. Train others where required.
• Participate in CAPA root cause investigation and actions implementation.
• Implement ongoing quality improvement processes working with cross functional teams.
• Acts as a consultant for areas related to his/her expertise.
• Performs other related duties as assigned by management.
• Quality Representative for contract review activities on existing products.
• Provides support as the primary Quality representative for Notices of Change (NOCs), Notices of Activity (NOAs), and Nonconforming Material Reports (NCRs) related to existing products in assigned areas.

Qualifications

• 2 to 5 years of relatable experience in a regulated industry is required.
• A Bachelor's degree in engineering or related discipline is required; it may substitute for some of the years of required experience and knowledge.
• Basic knowledge of ISO 13485:2016, ISO 14644-1 and FDA QSR.
• Strong root-cause investigator and problem solver within a manufacturing environment.
• Mechanical aptitude.
• Well-developed written and verbal communication skills. Ability to write and comprehend instructions, short correspondence, and memos.
• Internal Auditing capable.
• Experienced in statistical analysis.
• Ability to solve practical problems and deal with a variety of concrete variables and ability to interpret a variety of instructions furnished in written and oral form.
• Well versed in data management and graphical presentation of data.
• Experienced with Microsoft Windows, Outlook, Word, Excel, Microsoft Project, etc. is required.
• Generate reports using data analysis, SPC analysis/tools, etc. and effectively communicate findings/proposals to various users in the organization.

COMPANY COMPETENCIES:
• Diversity - Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; Educates others on the value of diversity; Promotes a harassment-free environment; Builds a diverse workforce.
• Ethics - Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
• Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.
• Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
• Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.

SUPERVISORY RESPONSIBILITIES:
• This job has no supervisory responsibilities.
 
JOB COMPETENCIES:
• Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
• Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
• Validation / Verification – Has a clear understanding of how to design and execute validation and verification activities as they pertain to new product development, process improvements and/or changes. 
• Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Utilizes data analysis to justify process changes.
• Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.

PHYSICAL DEMANDS AND WORK ENVIORNMENT:
• Occasionally required to stand
• Occasionally required to walk
• Frequently required to sit
• Occasionally required to climb, balance, bend, stoop, kneel or crawl
• Frequently required to talk or hear
• Occasionally work near moving mechanical parts