Engineer II, Quality Compliance

Job Description

Job Summary

The Senior Engineer, Quality Compliance will be responsible for the specific area of Analysis of Data in the Quality Compliance department. This position will interface with representatives from different departments within the organization (e.g. Quality Compliance, Quality Assurance, Engineering, and Operations) to prepare metrics for routine quality reviews and management reviews. This individual will also be responsible for assisting in the development of new processes within the Quality department. This person will utilize various technical skills to support activities within the Quality department.

Duties & Responsibilities

• Quality Metric Management:
  • Prepare metrics for routine quality reviews, Quality Compliance Council, and Management Reviews
  • Follow up with Process Owners to ensure actions are being completed per the requirements of the quality system
  • Establish reports to provide status on Quality activities
  • Identify and communicate opportunities to improve the quality management system
• Project Management:
  • Participate in and/or lead the implementation of projects relating to Quality Compliance and other process improvement initiatives
  • Develop project plans and work instructions
  • Provide project direction and support to project teams
  • Monitor and report on project progress to appropriate stakeholders
• Performs other duties or special projects as assigned;

Minimum & Preferred Qualifications and Experience

Minimum Qualifications

1. Three to five years, preferably in a regulated industry;
2. Advanced computer skills including: Word, Excel, PowerPoint, and management of spreadsheets and generating reports;
3. Effective judgment and interpersonal skills; and the ability to interface with all levels across the entire organization;
4. Sound organizational and planning skills with solid attention to detail;
5. Critical thinking and problem solving skills;

Skills required

• Strong Analytical Skills
• Excellent Communication skills
• Excellent Documentation skills
• Flexibility and adaptability
• Ability to work with minimal guidance from direct supervisor

Preferred Qualifications

• Strong communication and interpersonal skills with ability to work well in a high pressure environment.
• Minimum 3 years' experience working in high tech manufacturing environment.
• Direct experience within the medical device industry (FDA Regulated) is strongly preferred.
• Proven ability to demonstrate analytical capabilities (including statistical analysis, analytical capabilities etc.).
• Proven ability to demonstrate strong technical writing skills.
• Knowledge of FDA QSR and ISO Quality Standards.
• Strong competency in Customer Focus, Driving for Results, Integrity and Trust, Ethics and Values and Compassion.
• Proven ability to demonstrate at minimum, the following competencies: Action orientation, Perseverance, Dealing with Ambiguity, Learning on the fly and Problem Solving.

Education

Bachelors of Science degree required, preferably in an engineering discipline.

Compensation: The anticipated salary range for this position is $93,000-$120,000 plus benefits. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience. This position also qualifies for up to 10% annual bonus based on Company, department, and individual performance.

Physical requirements/Work Environment

This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.