Supplier Quality Engineer

Job Description

Job Description

Description:

The Supplier Quality Engineer manages supplier quality performance. You will evaluate, qualify, and monitor suppliers to ensure compliance with company standards and industry regulations. This role acts as the primary technical liaison between internal engineering and supply chain teams and external suppliers to prevent defects and drive continuous improvement.

• Conducts on-site and remote audits of supplier manufacturing lines and Quality Management Systems (QMS) to verify process capability and compliance.
• Leads root cause investigations for incoming material non-conformances. Works with suppliers to identify and address concerns and improve processes / quality.
• Generates supplier quality data reports and analyzes data for trends to drive continuous improvement. Tracks, analyzes, and reports key supplier quality metrics.
• Interfaces with suppliers, customers, manufacturing personnel, quality control personnel and management.
• Provides guidance to Quality Control incoming inspectors.
• Ensures proactive identification of systemic supplier concerns.
• Supports New Product Introduction (NPI)
• Provides quality support for supplier related validation activities (IQ/OQ/PQ…).
• Authors incoming inspection documentation. 
• Develops incoming inspection sampling plans and measurement / inspection techniques.
• Reviews and analyzes supplier data and reports, identifies trends, and makes recommendations for improvements.
• Communicates with internal teams and suppliers to ensure the timely resolution of quality issues.
• Performs other related duties as assigned.

Requirements:

• Previous experience as a Supplier Quality Engineer or a similar role
• Previous experience in a regulated industry such as medical devices is preferred
• Familiarity with Good Manufacturing Practices (GMP) and/or ISO 13485 is preferred
• Familiarity with process controls in a regulated manufacturing industry is preferred
• Excellent attention to detail
• Excellent verbal and written communication skills
• Excellent interpersonal skills

Education & Experience

• Minimum of five years experience in a Quality Engineering or a related role.
• Degree in Engineering or a related field preferred. 
• Understanding of industry standards and regulatory guidelines for equipment / process qualification and validation.
• Strong computer skills and experience with quality management software are a plus.
• Knowledge of statistics and Minitab is a plus.
• Experience with Six Sigma, lean manufacturing, or related methodologies is a plus.

Working conditions

• While performing the duties of this job, the employee occasionally works near moving mechanical parts and is occasionally exposed to wet and/or humid conditions, ambient air, fumes, or airborne particles.
• While performing the duties of this job, the employee will encounter prolonged periods of sitting at a desk, working on a computer, walking, talking or listening; use of hands and fingers to operate a computer, telephone and others office devices and reach with hands and arms.

Physical requirements

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• Ability to lift items weighing up to 50 lbs.

Pay: $90,000 - $115,000/year

Benefits: Eligible after 1st day:

• Paid holidays 
• Employee Assistance Program

Eligible after 90-day probation period:

• Medical, Dental, Vision, Basic Life/AD&D Insurance, Voluntary Term Life/AD&D Insurance
• Health Savings Account (HSA), Flexible Spending Account (FSA), Dependent Care Account, Commuter Transportation Management Account 
• Vacation time
• Sick time

Eligible after 1 year of service: 

• 401(k) with Employer Match
• Potential for discretionary bonus

The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job, the type of years and experience within the industry, education, etc.

We’re proud to be an equal opportunity employer. This means we actively pursue ways to celebrate our differences and don’t discriminate based on an individual’s race (including traits historically associated with race, such as hair texture, hair type, and protective hairstyles including braids, locks, and twists), creed, national origin, nationality, religion, ancestry, age (40 or over), sex (including pregnancy), familial status, marital status, civil union or domestic partnership status, affectional or sexual orientation, gender identity or expression, mental or physical disability (including perceived disability, AIDS, and HIV status), atypical hereditary cellular or blood trait, genetic information, because of liability for service in military, status as a smoker or non-smoker, status as a registered medical marijuana user, or any unlawful criterion existing under applicable federal, state, or local laws.

If you need assistance or an accommodation due to a disability, contact us at View email address on us.fitly.work.