Quality Engineer II

SUMMARY:

The Quality Engineer II is responsible for supporting process improvements, risk management activities, complaint process, design control activities, customer/ISO/FDA audits and non- conforming material as it relates to sustaining products.

The Quality Engineer II 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.

The Quality Engineer II may be asked to be a quality system process owner in which this role will actively manage one or multiple key components of the quality system.

DUTIES AND RESPONSIBILITIES:

• 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, interface with customers to gather necessary details, determine root cause and implement corrective and preventive actions.
• Interface with Engineering to drive continual improvement on existing manufacturing processes.
• Quality Representative for Design Control Activities for existing product lines.
• Release documents via the change control process as necessary. Train others where required.
• Prepare quality related deliverables in a timely manner.
• 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.
• Potential Quality System Process Owner for the following (but not limited to):

o Non-conforming Reports (NCR)

o Customer Complaints

o Supplier Quality

o Environmental Monitoring

o Corrective and Preventive Actions (CAPA)

o Internal Audits

o Training

Qualifications

QUALIFICATIONS:

• 3 to 8 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.
• Well-rounded knowledge of ISO 13485:2016 and FDA QSR.
• Strong root-cause investigator and problem solver within a manufacturing environment.
• Mechanical aptitude with manufacturing experience.
• Well-developed written and verbal communication skills. Ability to write and comprehend instructions, short correspondence, and memos.
• Must possess the ability to work semi-independently with little daily input from a manager.
• Experienced in statistical analysis.
• Certified Lead Auditor
• 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