Reports To: Chief Technology Executive and with dotted line to Chief Executive Officer
The Quality & Regulatory Assurance Manager is responsible for the overall Quality Policies, Procedures and Programs at HydroWorx. They will establish guidelines and systemic requirements for quality and regulatory compliance in support of ongoing and new projects.
This key position on the leadership team will drive major quality improvement projects with cross functional teams including but not limited to all Engineering, Manufacturing, Supply Chain, Marketing and Sales activities.
- Serves as the Quality & Regulatory key stakeholder for product development release team.
- Develops, implements and maintains Standard Operating Procedures and quality management systems to comply with federal and state regulations.
- Manages and lead efforts related to internal audits.
- Ensures quality products are developed in accordance to governing regulations and processes.
- Serves as key member of product risk assessment and leadership teams.
- Drives key quality requirements (e.g. Design for Test, Design for Reliability, etc.) in new product development.
- Participates and supports various development activities including design reviews and Product Safety Committee.
- Reviews and approves product design documentation.
- Interpret regulations and ensure compliance to departmental policies and procedures.
- Actively participates and/or leads Design History File audits and follow-on remediation efforts as required.
- Support root cause analysis activities for the investigation of product complaints.
- Actively participate and assist teams with Risk Analysis to include Risk Assessments, DFMEA/PFMEA’s, CAPA’s, etc.
- Assists in the planning and execution of verification and validation testing to ensure adequate test coverage for new products and sustaining design changes.
- Performs New Product Development (NPD) gate audits to ensure project deliverables adhere to governing processes.
- Responsible for managing all tool and process validations – reviews and approves all validation documentation.
- Reviews quality data to identify high priority issues relating to safety, complaints and systemic customer satisfaction.
- Perform other duties as assigned.
Education & Experience:
- BS Degree-in Engineering or other technical degree
- 7-10 years experience in quality engineering / quality assurance role under the Quality System Regulation, with medical device or other FDA regulated industry required
- Experience in New Product Development/ Medical Device Design required
- Knowledge of ISO Quality System Standards desired
- Experience with requirements management tools and systems engineering concepts desired
- CQA, CQE, CSQE, or RAC certification desired
- Ability to implement correction action programs
- Excellent analytical decision making and problem-solving skills
- Demonstrated ability to work and perform in team environments
- Strong presentation and communication skills
- Strong collaboration with other departments
- Strong analytical skills
- Attention to detail
- Conflict resolution and negotiation skills
- Proficient in Microsoft Office
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Self-motivated with a strong sense of ownership in areas of responsibility
- Highest degree of professionalism, ethics and integrity
- Able to think outside the box and adapt best practices to our growing environment
The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, copy and fax machines, filing cabinets.
Tools & Equipment:
Computer, telephone, copy & fax machines and company provided tools.
Monday through Friday, 8:00 a.m. to 5 p.m. Occasional evening and weekend work may be required as job duties demand
As required by the position, generally less than 10%
Training for this position will be conducted per HydroWorx Training Program.
Thank you for your interest in HydroWorx. Apply directly here.
EEO Statement: “HydroWorx International, Inc. is an Equal Opportunity/Affirmative Action employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran or disability status, or any other characteristic protected by law.”