Senior Quality Engineer

Job Description

Job Description

Job Description-Senior Quality Engineer

G&F Precision Molding Inc., Danvers, MA, is growing! We are agile, innovative, customer-centric, and our goal is to provide specialized, creative solutions and a commitment to ongoing service and quality. G&F Precision is unique; our core business is life science including medical devices and pharmaceuticals. We provide custom solutions to universal manufacturing needs. We have the experience, ability, and drive to tackle challenging projects from concept to execution.

Our work environment includes :

• Growth opportunities
• Safe work environment

We're seeking a dedicated Senior Quality Engineer to join our team. The ideal candidate will be responsible for implementing and maintaining multiple quality management system elements in accordance with company needs, based on current regulations, and organize and promote companywide quality improvement efforts. Occasional travel to our Fiskdale, MA location is required.

Job Type : Full-time Salary : $95,000 - $120,000 per year

Essential Job Duties and Responsibilities :

Leads and mentors Quality Auditors

Establishes procedures for maintaining high standards of quality, reliability, and safety

Supports the Quality Management System (ISO 13485)

Develops and supports process validation (IQ, OQ and PQ) as related to Quality functions.

Develops measurement methods, fixtures, and automated measurement programs based on requirements

Programs vision systems for automated measurements (OGP Smart Scope)

Reads, understands, and interprets GD&T drawings

Analyzes process capability results using Minitab

Coordinates Gage R&R and analyzes test results

Leads new product introduction projects

Performs root cause analysis and implement preventative and corrective actions

Acts as liaison with customers and suppliers on matters relating to quality

Works with Product Engineers for APQP process and part validations

Receives and complies with verbal and written directions

Performs and / or produces all work and / or product in conformance with G&F quality management system

Complies with all G&F Safety Rules, Policies and Procedures

Performs additional duties and functions of a related nature as assigned without notice

The Senior Quality Engineer reports to the Director of Quality.

Experience, Education and Training Requirements :

Minimum of 5-10 years of experience in quality assurance.

Four-year technical degree, preferably in a field that offers as opportunity to gain a well-rounded background with additional class work in problem-solving techniques (i.e., Statistical Quality Control / Statistical Process Control, Fishbone Diagrams, etc.) preferred.

Experience leading teams

Experience within the medical device industry and injection molding environment

Experience working with an ISO 13485 quality management system

Experience with quality audits

Experience developing quality and risk documentation (Process Flow Charts, FMEA’s, Control Plans, Work Instructions, etc.)

Experience with ISO9001 and / or ISO13485, preferred.

Strong written and verbal communication skills, along with excellent comprehension, in English required

Expert knowledge of GD&T

Knowledge of Solidworks

Vision System programming experience (QVI OGP SmartScope preferred)

Experience analyzing results of Statistical Process Control (SPC), Design of Experiment (D.O.E.), Gage R&R, and process capability; use of Minitab preferred

Understand formal IQ, OQ and PQ procedures

PC-DMIS SMM programming a plus

FDA Regulatory experience a plus

Physical - Must be able to complete all requirements with or without reasonable accommodation

Wear full Personal Protective Equipment while in cleanroom environment

Must be able to lift as much as 25 pounds at times.

Visual acuity to read instructions, operate machines, and inspect parts produced.

Benefits :

401(k)

401(k) matching

Dental insurance

Dependent care account

Employee assistance program

Flexible spending account

Health insurance

Health reimbursement account

Holidays (9)

Life insurance

Paid time off / Vacation

Parental leave

Professional development assistance

Tuition reimbursement

Vision insurance

Schedule :

Day shift, generally 8a-5p

Monday to Friday

Language :

English (Required)

Written (English Required)

Work Location and Mode :

At G&F Precision Molding, we value teamwork and collaboration. This role requires employees to be onsite, at one location, five days per week.

Occasional travel to our other site in Fiskdale, MA may be required.

Ability to commute / relocate :

Danvers, 01923 : Reliably commute or planning to relocate before starting work (Required)

Relocation Assistance :

Relocation assistance is not available for this position at this time.

Visa Sponsorship :

G&F Precision Molding will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.