Our medical technologies firm in Mahwah, NJ is looking for a Quality Engineer.
Provide quality engineering support in quality assurance, Advocate and lead the execution of initiatives & EUMDR project. Ensure compliance to regulation and standards. Will work within the quality operations team, with moderate supervision and mentoring, with responsibility for quality related activities.
- Having knowledge of and ability to provide Interpretation and Guidance on Regulations, Corporate, Divisional and Site Local procedures as they relate to validation activities.
- Discuss / give feedback in validations. Support executing, reviewing and approving Validation/Qualification Documentation.
- Working with Validation team and Consultants/Contractors as required ensuring that Validations are completed as per corporate and divisional procedures.
- Work closely with operations and the business functions to ensure quality performance of product and processes.
- Participate in the development and improvement of the manufacturing processes for existing and new products.
- Review of change management activities.
- Develop understanding of risk management practices and concepts, ability to become proficiency in process risk.
- Assist in the development and review of process and equipment validation/qualification. Build proficiency in validation processes.
- A minimum of a Bachelors Degree in English, Business, Technical Writing or related discipline
- Policy experience preferred but not required
- Other Skills
- Must have excellent verbal and written interpersonal communications skills
- Excellent analytical skills
- Exceptional skills in applicable Microsoft software programs
- Must be able to review printed and handwritten materials
- Must have an understanding of archiving systems and electronic document managing systems
- Must be able to organize with the ability to prioritize work and keep accurate and detailed records
- Must have excellent time management skills with the ability to use independent judgment effectively
- Must be able to understand and work within complex cross-functional procedures and policies
- Is a self-starter with demonstrated efficient work methods, analytical & problem-solving skills and ability to handle multiple tasks in a fast-paced environment
We put our Ambassadors first. When it comes down to it, we know we can't fulfill our Promise to our business customers without your commitment. You represent our organization while on assignment. In return, we do our best to show our commitment to you. Our Ambassador Benefits package includes: Medical, dental and vision coverage. It also includes 401k, sick time, holiday and much more. We are an equal opportunity employer.
We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.