Sr. Product Quality Engineer
42 Dunham Ridge Road Beverly, MA 01915 US
The responsibilities include assisting in examination and approval of components and finished products, equipment, processes and related documentation. Utilizing different tools and techniques, the Sr. Product Quality Engineer will help ensure that only products of the highest quality are delivered to our customers.
This is a full-time position, Monday through Friday, during normal business hours.
Pay Rate: $100,000K - $110,000K
- Lead MRB activities to include coordination, collection, analysis and distribution of monthly and quarterly quality metrics.
- Lead investigation of manufacturing nonconformities and assist in developing and implementing effective corrective actions.
- Apply analytical methods to assess product/process performance and quantify the effect of the change.
- Conduct internal QMS and manufacturing processes audits and participates in various internal and external audits.
- Apply Statistical Process Control (SPC) methods to evaluate current processes and process changes
- Collaborate and support company-wide CAPA and non-conformance implementation and continuous improvement projects
- Participate in supplier evaluation and selection process working with supplier to address supplier related nonconformities.
- Participate in risk assessment/management activities (i.e. FMEA) and the development of control plans
- Ensure compliance and operational effectiveness in all areas of the QMS including change control, training, complaint handling, CAPA, nonconforming process and auditing (internal and external).
- Collaborate with Product Development to ensure designs, procedures and outcomes are meeting customer and QMS requirements.
- Adhere to safety, environmental, and quality-related policies and procedures in the facility.
- Leading teams and projects using a fact-based problem-solving methodology (DMAIC or 8D).
- Basic metrology and GD&T
- Applying quality problem-solving methods like FMEA, SPC, control plans, etc.
- Working independently and collaboratively when making decisions.
- Analytical thinking, attention to detail, problem-solving, and failure analysis aptitude
- Statistical methods (i.e, MSA, process capability analyses, experiment design).
- Developing, writing and implementing processes and procedures.
- Manufacturing processes in an ISO 9001, AS 9100 or other regulated industries.
- Strong data management, synthesis, and interpretation capabilities.
- A strong quality mindset with the ability to handle tight deadlines, and manage multiple priorities.
Required Education and Experience
- Bachelor's degree in an Engineering discipline
- Minimum of 8 years of overall Engineering experience in an ISO (FDA is a plus) regulated environment
- Minimum of 5 years in a direct Quality role is required
- Proficient with Microsoft Word, Excel & PowerPoint. Minitab or other statistical software suites
Must be able to complete a pre-employment physical and 11-panel drug screen that includes THC.
All interested candidates should apply directly to this ad or contact Chris or Julie at Schulte Staffing 978-594-0497
***This position is restricted to U.S. citizens due to U.S. government contract regulations that require the employment of only persons who are U.S. citizens. Must have the ability to obtain a DOD Security Clearance***
Meet Your Recruiter
Brad has been in the staffing industry for "far longer than he would like to admit.” Brad brings over 20 years of sales, operations, management and recruiting experience and industry knowledge to Schulte Staffing. Brad offers career counseling and resume reviews for our candidates in addition to providing guidance on customized client staffing programs. When Brad is not offering career advice to our candidates, he is "offering" advice to his five children. Brad coordinates an annual family turkey drive feeding 50 local families a complete Thanksgiving dinner. He enjoys his beloved Red Sox, cooking and taking day trips along the coast.